[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-arterial-hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-arterial-hypertension":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,50,64,96,118,140,161,191,214,235,258,272,299,326,350,376,396,420,444,466,488,532,580,602,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100053350","phase-3-fibrotic-disease-activity-in-cardiopulmonary-disorders-using-18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-petct-imaging-100053350",false,"NCT07613099","Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET\u002FCT Imaging","Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET\u002FCT Imaging)","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participant \\>=18 years old\n4. Has a specific diagnosis of a cardiopulmonary and\u002For vascular disease that puts them at risk of developing or having developed tissue fibrosis.\n5. Has undergone prior imaging of lungs, heart, and\u002For vasculature with chest CT\n6. Able to lie on the PET\u002FCT scanner for imaging up to 45 minutes.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.\n2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements\n3. Pregnancy or lactation\n4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET\u002FCT scan or the FDG PET\u002FCT scan.\n5. Subjects with severe claustrophobia unresponsive to oral anxiolytics.\n6. Subjects weighing \\> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry","ALL","18 Years","100 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....",[28,29,30,31,32,33],"Allogeneic Stem Cell Transplantation","Lung Allograft Transplantation","Interstitial Lung Disease","Acute Lung Injury","Pulmonary Arterial Hypertension","Cardiovascular Diseases",[35,36],"Fibroblast activation protein (FAP) FAPI\u002FPET","Fibrotic Disease Activity","NOT_YET_RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":22},"2026-07-16",{"date":45,"type":22},"2033-05-26",{"name":47,"class":48},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":51,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":49},"100641631",{"count":21,"type":22},[25],"Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated.",[28,29,30,31,32,33],[35,36],"2026-07-01",{"date":59,"type":41},"2026-07-02",{"date":61,"type":22},"2026-07-07",{"date":45,"type":22},{"name":47,"class":48},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100638083","phase-1-diag723-in-adults-with-hereditary-hemorrhagic-telangiectasia-100638083","NCT07623525","DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia","A Phase 1\u002F2, First-in-Human, Multicenter, Ascending Single-Dose and Multi-Dose Study to Assess the Safety of DIAG723, a Novel Bispecific ALK-1 and BMPRII Agonist Antibody in Adult Patients With Hereditary Hemorrhagic Telangiectasia (DIAMOND Trial)","DIAMOND","Inclusion Criteria:\n\n* Adult patients ≥18 years with a clinical or genetic diagnosis of HHT\n* Adequate hepatic and renal function\n* Part B: Epistaxis and anemia or transfusion\u002Firon history\n* Part C: HHT with documented pre-capillary pulmonary arterial hypertension\n\nExclusion Criteria:\n\n* Active or recent systemic infection\n* Recent thromboembolic events\n* Use of anti-angiogenic drugs within 6 weeks\n* Pregnancy or lactation\n* Recent participation in another investigational study",{"count":73,"type":22},93,[75,76],"PHASE1","PHASE2","This is a Phase 1\u002F2, randomized, double-blind, placebo-controlled, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of subcutaneously administered DIAG723 in adult patients with hereditary hemorrhagic telangiectasia (HHT).\n\nThe study consists of three parts:\n\nPart A (dose escalation): Single ascending subcutaneous doses of DIAG723 are evaluated in sequential cohorts to assess safety, tolerability, and pharmacokinetics.\n\nPart B (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT to assess safety and preliminary efficacy.\n\nPart C (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT and concomitant pulmonary arterial hypertension to assess safety and exploratory clinical effects in this population.\n\nParticipants will be randomized within each study part to receive DIAG723 or placebo. The study includes dose escalation in Part A and dose expansion in Parts B and C.",[79,32],"Hereditary Hemorrhagic Telangiectasia",[79,81,82,83,84],"HHT","BMPRII","ALK1","Bone morphogenetic protein receptor type II","RECRUITING","2026-06-30",{"date":59,"type":41},{"date":89,"type":41},"2026-06-04",{"date":91,"type":22},"2027-12-31",{"name":93,"class":94},"Diagonal Therapeutics, Inc.","INDUSTRY",5,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":49},"100187213","phase-2-spironolactone-for-pulmonary-arterial-hypertension-100187213","NCT01712620","Spironolactone for Pulmonary Arterial Hypertension","A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension","* INCLUSION CRITERIA:\n\n  1. WHO Group 1 PH patients on either no medical therapy or stable medical therapy for at least the past 4 weeks (defined as no new PAH-specific therapy, no change in the dose of current PAH-specific therapy and no change in NYHA\u002FWHO functional classification within the past 4 weeks) are eligible. The following parameters on RHC are required to meet the hemodynamic definition of PAH:\n\n  \u003C!-- -->\n\n  1. mean pulmonary artery pressure of \\> 25 mmHg at rest,\n  2. pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12 mmHg) and\n  3. pulmonary vascular resistance of \\> 3 Wood units (240 dyn.s.cm\\^-5).\n\nIf clinically indicated at the time of enrollment, then a RHC will be performed at the NIH Clinical Center upon study entry under a procedural consent.\n\n2\\) Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and for the duration of study participation.\n\nEXCLUSION CRITERIA:\n\n1. Patients with WHO Group 1 PH and evidence of right heart failure as defined by:\n\n   1. NYHA\u002FWHO class IV symptoms and\n   2. Echocardiographic evidence of severe RV dysfunction and\n   3. Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, and lower extremity edema\n2. Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites, hepatic encephalopathy and\u002For varices prior to enrollment\n3. Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of \\\u003C 500 on their most recent determinations within the past 12 months will be considered to have inactive infection)\n4. Patients with WHO Group 1 pulmonary hypertension who have taken spironolactone or eplerenone within the last 30 days\n5. Known or suspected allergy to spironolactone\n6. Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n7. Age \\\u003C18 years\n8. Inability to provide informed written consent for participation in the study\n9. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 35 mL\u002Fmin\u002F1.73m\\^2 of body surface area)\n10. Serum potassium at the time of enrollment of \\> 5 mEq\u002FL\n11. Concurrent use of an ACE inhibitor and angiotensin II receptor blocker\n\n    OR\n\n    Patients currently taking the maximum recommended dose of an ACE inhibitor or an angiotensin II receptor blocker \\[For patients taking one of these medicines (ACE-Inhibitors or ARBs), the investigators agree to do due diligence by consulting a clinical center pharmacist and\u002For a standard pharmacy reference (i.e. Micromedex) to certify whether or not the patient is on a maximum dose of the drug.\\]\n12. Women currently taking drospirenone-containing oral contraceptives\n\nThe estimated glomerular filtration rate (eGFR) will be calculated using the IDMS-traceable Modification of Diet in Renal Disease (MDRD) equation and corrected for body surface area.\n\neGFR = 175 x (serum creatinine in mg\u002FdL)\\^-1.154 x (age in years)\\^-0.203 x \\[1.212 if African-American\\] x \\[0.742 if female\\]\n\n(http:\u002F\u002Fwww.nkdep.nih.gov\u002Fprofessionals\u002Fgfr\\_calculators\u002Fidms\\_con.htm)\n\nExclusion Criteria for MRI\n\nThese contraindications include but are not limited to the following devices or conditions:\n\n1. Implanted cardiac pacemaker or defibrillator\n2. Cochlear Implants\n3. Ocular foreign body (e.g. metal shavings)\n4. Embedded shrapnel fragments\n5. Central nervous system aneurysm clips\n6. Implanted neural stimulator\n7. Any implanted device that is incompatible with MRI\n8. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest\n9. Subjects requiring monitored sedation for MRI studies\n10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)\n11. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n\nEXCLUSION CRITERIA FOR GADOLINIUM BASED MRI STUDIES ONLY:\n\n1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone\n2. Chronic kidney disease (an estimated glomerular filtration rate of \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 of body surface area)",{"count":104,"type":22},70,[76],"Background:\n\n\\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to worsening of the disease. A drug called spironolactone has been known to improve blood vessel function and reduce inflammation. Some people with PAH take spironolactone to help treat fluid retention. However, its effect on inflammation and blood vessel function in patients with PAH is not known. Researchers want to see if spironolactone can help these conditions in people with PAH.\n\nObjectives:\n\n\\- To test the effectiveness of spironolactone in treating pulmonary arterial hypertension.\n\nEligibility:\n\n\\- Individuals at least 18 years of age with pulmonary arterial hypertension.\n\nDesign:\n\n* This study will last for 24 weeks. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.\n* Participants will take either spironolactone or a placebo. They will take their study drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests.\n* In Week 8, participants who have had no reaction to the treatment will receive a higher dose of the drug or placebo.\n* In Week 12, participants will have a study visit with heart and lung function tests. They will also have a 6-minute walk test, and provide blood and urine samples.\n* After additional study visits for blood samples, participants will have a final visit in Week 24. The tests from Week 12 will be repeated at this visit.",[32],[109],"Magnetic Resonance Imaging","2026-06-27",{"date":86,"type":41},{"date":113,"type":41},"2014-01-10",{"date":115,"type":22},"2026-12-31",{"name":117,"class":48},"National Institutes of Health Clinical Center (CC)",{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100638004","phase-4-a-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-pah-in-india-mk-7962-037-100638004","NCT07600723","A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037)","A Phase 4, Prospective, Open-label, Single-Arm Study to Evaluate the Safety of Sotatercept in Adults With Pulmonary Arterial Hypertension (PAH) in India","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has documented historical diagnostic right heart catheterization (RHC), with the diagnosis of pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH), in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug\u002Ftoxin-induced PAH, PAH associated with connective tissue disease, and PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair\n* Has been on stable doses of PAH background therapies and diuretics (if applicable)\n* Has symptomatic PAH classified as World Health Organization (WHO) Functional Classification (FC) II or III\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of Groups 2, 3, 4, or 5 PH\n* Has a diagnosis of the following PAH (Group 1 PH) subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, PAH diagnosed with pulmonary veno occlusive disease (PVOD) or pulmonary capillary hemangiomatosis (PCH)\n* Has uncontrolled systemic hypertension\n* Has a history of full or partial pneumonectomy\n* Has untreated more than mild obstructive sleep apnea\n* Has known history of portal hypertension or chronic liver disease, including hepatitis B and\u002For hepatitis C\n* Has a history of restrictive, constrictive, or congestive cardiomyopathy\n* Has significant mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis, and more than mild aortic valve stenosis\n* Has known malignancy that is progressing or has required active treatment within the past 5 years",{"count":126,"type":22},30,[128],"PHASE4","Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.\n\nResearchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.\n\nThe goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.",[32],"2026-06-25",{"date":133,"type":41},"2026-06-29",{"date":135,"type":22},"2026-07-15",{"date":137,"type":22},"2028-04-03",{"name":139,"class":94},"Merck Sharp & Dohme LLC",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100609703","phase-3-a-clinical-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-mk-7962-038-100609703","NCT07218029","A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)","An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)","SOTERIA","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early\n* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements\n* Must have the ability to understand and provide documented informed consent\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Did not participate in a sotatercept PAH parent study\n* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept\n* Is a female who is pregnant or breastfeeding\n* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study\n* Is currently enrolled in another investigational product study other than a sotatercept study\n* Is incapacitated",{"count":149,"type":22},815,[25],"Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.\n\nSotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.\n\nThis is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.",[32],{"date":154,"type":41},"2026-06-26",{"date":156,"type":41},"2021-05-12",{"date":158,"type":22},"2028-12-07",{"name":139,"class":94},126,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":49},"100643944","multimodality-rv-phenotyping-for-risk-stratification-and-short-term-outcomes-in-group-1-pah-100643944","NCT07667673","Multimodality RV Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 PAH","Multimodality Imaging-Based Right Ventricular Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 Pulmonary Arterial Hypertension: The MIRROR-PAH Study","MIRROR-PAH","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of Group 1 pulmonary arterial hypertension (PAH) according to ESC\u002FERS guidelines\n* Followed at the study center with a diagnosis of PAH\n* Availability of right heart catheterization (RHC) and cardiac magnetic resonance (CMR) imaging data obtained within a clinically relevant time interval\n* Availability of analyzable clinical, imaging, and hemodynamic data\n* Willingness to participate in the study and provision of written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Pulmonary hypertension groups other than Group 1 PAH (Groups 2-5 PH)\n* Absence of either right heart catheterization or cardiac magnetic resonance imaging data within a clinically relevant time interval\n* Incomplete clinical or imaging data preventing analysis\n* Unavailable follow-up data",{"count":170,"type":22},50,"OBSERVATIONAL","The MIRROR-PAH is a single-center, prospective, observational cohort study evaluating the incremental value of multimodality imaging-derived right ventricular characteristics for risk stratification in patients with Group 1 pulmonary arterial hypertension (PAH). The study aims to determine whether incorporation of echocardiographic and cardiac magnetic resonance (CMR)-derived right ventricular parameters into established non-invasive risk assessment models results in risk reclassification and improves identification of patients at risk for short-term clinical worsening.\n\nAdult patients with established Group 1 PAH undergoing routine follow-up and with available right heart catheterization (RHC) and CMR data will be consecutively enrolled. Clinical, laboratory, echocardiographic, and follow-up data will be prospectively collected over a 6-month period. Associations between multimodality imaging findings, invasive hemodynamic measurements, risk classification, and short-term clinical outcomes will be evaluated.",[174,32,175],"Pulmonary Hypertension","Right Ventricular Function",[177,178,179,180,181],"pulmonary arterial hypertension","transthoracic echocardiography","cardiac magnetic resonance imaging","right heart catheterization","risk stratification","2026-06-19",{"date":131,"type":41},{"date":185,"type":41},"2026-05-11",{"date":187,"type":22},"2027-05",{"name":189,"class":190},"Istanbul University - Cerrahpasa","OTHER",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100529618","phase-2-clinical-trial-of-2-hoba-in-pulmonary-arterial-hypertension-100529618","NCT06176118","Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Adults aged 18 or older\n* Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n* FEV1\\> or = 60% predicted and no more than mild abnormalities on lung imaging\n* WHO Functional Class II-IV\n* Ambulatory\n\nExclusion Criteria:\n\n* Sensitivity to 2-HOBA\n* Sensitivity to aspirin or salicylates\n* Aspirin-related rhinitis or wheezing\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane\u002Fwalker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins\n* Drug and toxin associated PAH patients with active drug use\n* Prior diagnosis of cirrhosis\n* Malignancy\n* eGFR by MDRD \\\u003C60mL\u002Fmin\n* Non-english speaking",{"count":198,"type":22},12,[76],"Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.",[32],[203,174,204],"2-hoba","Right Ventricular","2026-06-15",{"date":207,"type":41},"2026-06-17",{"date":209,"type":22},"2026-09-01",{"date":211,"type":22},"2027-12",{"name":213,"class":190},"Vanderbilt University Medical Center",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100641996","phase-2-a-study-of-sotatercept-mk-7962-in-japanese-children-with-pulmonary-arterial-hypertension-pah-mk-7962-032-100641996","NCT07646860","A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)","A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization\n* Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt\n* Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV\n* Has been receiving stable standard-of-care background therapy for PAH for at least 90 days\n* Is Japanese\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of left-sided heart disease\n* Has severe congenital or developmental abnormalities of the lung, thorax, and\u002For diaphragm\n* History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days\n* Has unrepaired or residual cardiac shunt with Qp\u002FQs \\>1.5\n* Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and\u002For venous involvement\n* PAH associated with portal hypertension\n* Known visceral arteriovenous malformations\n* History of full or partial pneumonectomy\n* Untreated more than mild obstructive sleep apnea\n* History of known pericardial constriction\n* Family history of sudden cardiac death or long QT syndrome\n* History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months\n* Prior treatment with sotatercept or luspatercept","1 Year","17 Years",{"count":224,"type":22},6,[76],"The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.",[32],"2026-06-09",{"date":205,"type":41},{"date":231,"type":22},"2026-08-31",{"date":233,"type":22},"2031-05-16",{"name":139,"class":94},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100630000","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-once-daily-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-pulmonary-arterial-hypertension-pah-100630000","NCT07481981","A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension","PALM-PAH","Inclusion Criteria\n\n* Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC\u002FERS) Guidelines:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug\u002Ftoxin-induced PAH\n  * Connective tissue disease (CTD)-associated PAH\n  * PAH associated with congenital heart disease-related to simple systemic-to-pulmonary shunt at least 1 year following repair.\n* PAH diagnosis for at least 3 months prior to Screening.\n* New York Heart Association (NYHA) or World Health Organization (WHO) functional class II-IV.\n* Participants must be on stable PAH therapy consisting of 1 to 3 medications from the following classes:\n\n  * Endothelin receptor antagonists (eg, ambrisentan, bosentan, macitentan) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Guanylate cyclase stimulator (eg, riociguat) for at least 90 days prior to Screening with the last 30 days on stable dose\n  * Activin signaling inhibitor (e.g., sotatercept) for at least 6 months prior to Screening, with the last 3 months on stable dose and meeting all the following conditions:\n\n    * no active clinically significant bleeding (eg, epistaxis and gingival bleeding requiring medical interventions) within the past 3 months.\n    * no history of major bleeding events or risks (eg, gastrointestinal or intracranial bleeding) within the past 6 months.\n    * platelet counts ≥100,000 per microlitre (μL) at Screening\n  * For both 6-minute walk tests (6MWTs), the values of 6-minute walk distance (6MWD) should be ≥ 150 and ≤ 450 meters at Screening.\n* Right heart catheterization (RHC) at Screening (or within 6 months prior to Screening, if available). Prior RHC may be used provided there has been no change in background PAH therapy and doses. The RHC must meet all of the following hemodynamic criteria:\n\n  * Mean pulmonary arterial pressure (PAP) \\>20 millimetre of mercury (mmHg) at rest.\n  * pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg.\n  * pulmonary vascular resistance (PVR) of ≥5 wood units (WU).\n\nExclusion Criteria\n\n* Diagnosis of PH WHO Groups 2, 3, 4, or 5, or subtypes of PH WHO Group 1 other than described in inclusion criterion 2 (eg, human immunodeficiency virus (HIV), complex congenital heart disease-associated PAH, portal hypertension-associated PAH, pulmonary veno-occlusive disease, Schistosomiasis associated PAH).\n* Clinically significant left heart disease, including left-sided valvular disease, left ventricular systolic or diastolic dysfunction, echocardiographic findings suggestive of post-capillary pulmonary hypertension, unstable ischemic heart disease, or unstable arrhythmias.\n* Evidence of airflow obstruction defined by forced expiratory volume in 1 second (FEV1) per forced vital capacity (FVC) \\\u003C0.7.\n* Evidence of significant restrictive lung disease as evidenced by FVC \\\u003C70% predicted normal.\n* Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine).\n* Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and\u002For insufficiently understood disease and\u002For may present an unreasonable risk to the study participant as a result of his\u002Fher participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","75 Years",{"count":245,"type":22},344,[25],"The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.",[32],[32],{"date":251,"type":41},"2026-06-10",{"date":154,"type":22},{"date":254,"type":22},"2029-01-28",{"name":256,"class":94},"Insmed Incorporated",2,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":265,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":269,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":270,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":271,"locationsCount":4},"100588303","an-expanded-access-study-to-assess-treprostinil-palmitil-inhalation-powder-tpip-for-participants-with-pulmonary-arterial-hypertension-pah-and-pulmonary-hypertension-associated-with-interstitial-lung-disease-ph-ild-100588303","NCT06939647","An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease","Inclusion Criteria\n\n* The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for PAH or PH-ILD.\n* Participant provides their informed consent to participate as per local requirements.\n* Participant must have successfully completed the OLE INS1009-203 or INS1009-212 studies.\n* Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program.\n* Requests for the post-OLE INS1009-203 and INS1009-212 TPIP studies must originate from the investigators of INS1009-203 and INS1009-212 TPIP studies, respectively.\n* Female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate \\\u003C1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.\n* Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo\u002Ffetus based on the partner's reproductive status. For partners of childbearing potential, effective contraception must be used from Day 1 to at least 90 days after the last dose.\n\nExclusion Criteria:\n\n• No specific exclusion criteria.","EXPANDED_ACCESS","The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.",[32,268],"Pulmonary Hypertension, Interstitial Lung Disease","AVAILABLE",{"date":251,"type":41},{"name":256,"class":94},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":49},"100502681","phase-4-pulmonary-hypertension-intensification-and-personalisation-of-combination-rx-100502681","NCT05825417","Pulmonary Hypertension: Intensification and Personalisation of Combination Rx","A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension (PAH) Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices (CardioMEMS\u002FConfirmRx)","PHoenix","Inclusion Criteria:\n\n* Able to provide informed consent\n* Age 18-80 years\n* PAH which is idiopathic, heritable or associated with drugs, toxins or connective tissue disease\n* Stable PAH therapeutic regime comprising any combination of ERA and PDE5i for at least 1 month prior to screening (unless unable to tolerate therapy)\n* WHO functional class III\n* Resting mPAP ≥20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, pulmonary vascular resistance ≥2 Wood Units measured by right heart catheterisation at time of diagnosis\n* 6MWT \\>50m at entry\n* Estimated glomerular filtration rate (eGFR)\\>30 ml\u002Fmin\u002F1.73 m² at entry (Appendix C)\n* Inadequate treatment response (clinically determined)\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Pregnancy\n* Unprovoked pulmonary embolism (at any time)\n* Acute infection at time of screening (rescreening is permitted)\n* PAH due to human immunodeficiency virus, portal hypertension, schistosomiasis, congenital heart disease\n* Pulmonary hypertension due to left heart, lung, thromboembolic or unclear\u002Fmultifactorial disease (Group II-V)\n* Unable to tolerate aspirin or P2Y12 inhibitor\n* Hypersensitivity to selexipag or riociguat\n* Clinically-significant renal disease (eGFR≤30 ml\u002Fmin\u002F1.73m2)\n* Anaemia (haemoglobin \\\u003C10 g\u002Fdl)\n* Left-sided heart disease and\u002For clinically significant cardiac disease, including but not limited to any of the following: aortic or mitral valve disease greater than mild aortic insufficiency; mild aortic stenosis; mild mitral stenosis; or moderate mitral regurgitation","80 Years",{"count":282,"type":22},40,[128],"The goal of this clinical trial is to evaluate the capacity of implantable\u002Fremote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans",[32],[287,288,289],"remote monitoring","therapeutic development","personalised medicine","2026-06-03",{"date":292,"type":41},"2026-06-05",{"date":294,"type":41},"2023-06-14",{"date":296,"type":22},"2027-01",{"name":298,"class":190},"Sheffield Teaching Hospitals NHS Foundation Trust",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":316,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100639334","phase-3-a-phase-3-study-of-extended-release-tacrolimus-in-subjects-with-pulmonary-arterial-hypertension-and-functional-limitations-100639334","NCT07612657","A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations","A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications","TRANSCEND","Inclusion Criteria:\n\n* WHO Group 1 PH: Pulmonary Arterial Hypertension;\n* WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;\n* Right heart catheterization (RHC) at screening (or within 3 months prior to screening);\n* Screening 6MWD \\>75 meters to ≤450 meters.\n\nExclusion Criteria:\n\n* PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis\n* Chronic thromboembolic or portopulmonary hypertension\n* Total Lung Capacity (TLC) \\\u003C60% predicted;\n* FEV1\u002FFVC \\\u003C70% predicted or FEV1 \\\u003C60% predicted;\n* Evidence of left-sided heart disease;\n* Inability to safely attempt completion of the 6MWD;\n* Life expectancy \\\u003C6 months;\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI equation);\n* Moderate to severe hepatic dysfunction (Child-Pugh score \\>10);\n* Serum potassium \\>5.1 mEq\u002FL;\n* Use of experimental PAH treatments within the past 3 months;\n* Active infection requiring antibiotic, antifungal, or antiviral therapies;\n* Current systemic treatment with cyclosporine;\n* Known allergy or hypersensitivity to tacrolimus;\n* Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment",{"count":308,"type":22},300,[25],"This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.",[32,312,313,314,315],"Pulmonary Arterial Hypertension (PAH)","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","Pulmonary Arterial Hypertension PAH","Pulmonary Arterial Hypertension WHO Group I",[317,32],"PAH","2026-05-22",{"date":320,"type":41},"2026-05-29",{"date":320,"type":22},{"date":323,"type":22},"2029-11-30",{"name":325,"class":94},"VIVUS LLC",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":332,"sex":333,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":257},"100616946","a-prospective-longitudinal-observational-cohort-study-of-pregnant-women-residing-at-high-altitude-in-bolivia-100616946","NCT07312227","A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia","Inclusion Criteria:\n\n* women delivering at participating hospitals at more than 3500 meters or women delivering at participating hospitals at sea level\n* signed informed consent\n\nExclusion Criteria:\n\n* preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA \\> III)",true,"FEMALE","45 Years",{"count":336,"type":22},27,"In this study, the investigators will follow two small cohorts of pregnant women: a cohort of healthy women with uncomplicated pregnancies residing at high altitude, a control group of healthy women with uncomplicated pregnancies residing at sea level, to characterize differences in cardiopulmonary adaptation and nitric oxide (NO) pathway expression at elevations \\>3,500 m throughout pregnancy and into the postpartum period. The investigators aim to investigate right-sided cardiac impairment induced by chronic hypobaric hypoxemia, its effects on fetal growth, and the potential contribution of cardiovascular nitric oxide depletion to obstetric complications.",[339,32,340],"Hypertensive Disorder of Pregnancy","Intrauterine Growth Restriction","2026-05-21",{"date":343,"type":41},"2026-05-26",{"date":345,"type":41},"2026-02-11",{"date":347,"type":22},"2027-02",{"name":349,"class":190},"Massachusetts General Hospital",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":49},"100621150","exercise-intervention-as-an-adjunct-to-medical-therapy-in-newly-diagnosed-patients-with-pulmonary-arterial-hypertension-100621150","NCT07366879","Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension","Randomised Controlled Trial of Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Aged 18-years-old and above\n* Diagnosed with pulmonary hypertension (group I and non-operable group IV) by right heart catheterisation showing:\n\n  * a baseline mean pulmonary artery pressure \\>20mmHg\n  * pulmonary vascular resistance \\>2 Wood Units\n  * pulmonary capillary wedge pressure \\\u003C15mmHg\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis with pulmonary hypertension of any other cause\n\n  * Group II (PH due to left heart disease)\n  * Group III (PH due to hypoxic lung disease)\n  * Operable group IV (PH due to chronic thromboembolic disease amenable to surgical treatment)\n  * Group V (unclear and\u002For multifactorial elements).\n* Planned treatment with a research trial medication during the study timeframe\n* Consenting clinician and\u002For patient concern regarding the patient's safety in performing a home-based exercise programme\n* Patients with syncopal episodes felt to be related to pulmonary hypertension at time of exercise intervention initiation.\n* Severe concurrent medical condition that would prevent participation in study procedures\n* Life expectancy \\\u003C3 months",{"count":282,"type":22},[359],"NA","The goal of this clinical trial is to learn if an exercise programme started shortly after diagnosis improves the fitness and mental wellbeing of patients with pulmonary hypertenion over and above medication alone. It will also learn about whether extra support can help patients keep up with exercise in the long term. The main questions it aims to answer are:\n\n* Doe exercise improve how far patients can walk over six minutes\n* Does exercise improve quality of life scores\n* Does exercise improve mental health scores\n* Does extra support after an exercise programme help patients to continue exercising in the long term\n\nResearchers will compare the exercise programme to a control group (a group of similar patients who do not receive the exercise programme) to see the effect that exercise has.\n\nParticipants in the exercise programme group will:\n\n* Undergo an exercise programme for 12 weeks, starting around 3 months after their diagnosis\n* They will undertake the exercise programme at home, remotely supervised by the research team with regular contact\n* Visit the clinic at the end of the programme for checkups and tests\n* Keep a diary of their exercise and how they are feeling\n\nParticipants in the control group will:\n\n-Still undergo the exercise programme, but this will happen at a delayed time, starting around 6 months after diagnosis, to allow for a comparison between the two groups.\n\nFollowing completion of the exerise programme:\n\n* Half of participants will receive extra support to help them continue to exercise\n* The other half will not receive any additional support\n* All patients will be reviewed 1 year following the completion of their exercise programme to monitor their ongoing exercise levels.",[32],[177,317,363,364,365],"pulmonary hypertension","exercise training","exercise adherence","2026-05-12",{"date":368,"type":41},"2026-05-13",{"date":370,"type":41},"2026-04-02",{"date":372,"type":22},"2028-01",{"name":374,"class":375},"Golden Jubilee National Hospital","OTHER_GOV",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":257},"100621031","phase-3-an-adaptive-program-of-ikt-001-in-pulmonary-arterial-hypertension-pah-100621031","NCT07365332","An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)","An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)","IMPROVE-PAH","Inclusion Criteria:\n\n* Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:\n\n  * Idiopathic PAH\n  * Heritable PAH\n  * Drug\u002Ftoxin-induced PAH\n  * PAH associated with connective tissue disease (CTD)\n  * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair\n* Men and women 18 and 75 years of age (inclusive)\n* Must have a body mass index (BMI) of ≥18.5 kg\u002Fm\\^2 and ≤35.0 kg\u002Fm\\^2 at screening.\n* Baseline RHC performed during the Screening Period documenting a PVR of ≥ 400 dyn\u002Fsec\u002Fcm\\^5 ; pulmonary capillary wedge pressure (PCWP) ≤15 mmHg and mean pulmonary artery pressure (mPAP) \\>20 mmHg. PVR enrichment criteria to ensure population baseline PVR \\>700 dynes\u002Fsec\u002Fcm\\^5\n* On stable doses of background PAH therapy including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days prior to screening. Current use of sotatercept is not permitted.\n* 6MWD ≥ 100 and ≤ 475 m\n\nExclusion Criteria:\n\n* Diagnosis of PAH WHO Groups 2, 3, 4, or 5.\n* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, and pulmonary veno-occlusive disease.\n* Any of the following blood pressure-related values or abnormalities: Uncontrolled systemic hypertension as evidenced by sitting systolic BP \\>160 mmHg or sitting diastolic BP \\>100 mmHg at screening, Baseline systolic BP \\\u003C90 mmHg at screening, Syncope within 3 months prior to screening\n* History of restrictive, constrictive, or congestive cardiomyopathy.\n* ECG with Fridericia's corrected QT interval (QTcF) ≥ 450 msec in males or ≥ 470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.\n* Personal or family history of long QT syndrome or sudden cardiac death.\n* Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.\n* Forced vital capacity (FVC) \\\u003C70 percent on pulmonary function test (PFT) performed no more than 6 months prior to screening; or if FVC is 60 percent to 69 percent, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.\n* History of atrial fibrillation or atrial flutter.\n* History of cerebrovascular accident, intracranial hemorrhage, or subdural hematoma at anytime, or a fall associated with head trauma within 3 months of screening.\n* Acutely decompensated right heart failure within 30 days prior to screening, as per investigator assessment.\n* Clinically significant ischemic, valvular, constrictive heart disease, or heart failure with preserved ejection fraction in the opinion of the investigator.\n* History of pneumonectomy.\n* Untreated or inadequately treated (in the opinion of the investigator) obstructive sleep apnea.\n* Acute or chronic hepatitis B or C infection, defined as:\n\n  * Hepatitis B virus: a positive hepatitis B surface antigen test or a positive hepatitis B core antibody test with detectable DNA\n  * Hepatitis C virus (HCV): a positive hepatitis C antibody test with detectable HCV ribonucleic acid (RNA).Participants with a positive hepatitis C antibody test, but no detectable HCV RNA who completed treatment with direct-acting antivirals may be considered after discussion with the medical monitor.\n* History of or currently diagnosed with a bleeding disorder, including but not limited to hemophilia, von Willebrand disease, thrombocytopenia, or significant bleeding history defined as any bleeding event requiring medical intervention.\n* Received treatment with any of the following excluded medications:\n\n  * Currently receiving strong cytochrome P450 (CYP) 3A inducers or CYP3A inhibitors (except for topical administration)\n  * Currently receiving or anticipated need to receive any anticoagulant (e.g., heparins, vitamin K antagonists, direct oral anticoagulants, or direct thrombin inhibitors).\n  * Current use of sotatercept. Note: participants who previously received sotatercept may be considered if the last dose administered was \\>6 months prior to screening, participant had no significant bleeding events while on sotatercept.\n* Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to screening or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).\n* History of atrial septostomy within 180 days prior to screening.\n* Current participation in another investigational clinical trial and\u002For receipt of any investigational medication within 90 days prior to screening.\n* Previous randomization into this or another IKT-001 study.\n* Any social, behavioral, or medical reason that would preclude completion of the study, in the judgement of the investigator.\n* Currently lactating, pregnant or planning on becoming pregnant during the study.\n* Prior receipt of a solid organ transplant or stem cell transplant.\n* Planned surgery that would require any study drug interruption or interfere with study assessments during the study (minor procedures may be allowed in consultation with the medical monitor).\n* Malignancy within the last 5 years prior to consent except completely treated non-metastatic-basal cell, squamous cell, in situ cervical cancer, and clinically localized National Comprehensive Cancer Network very low to low risk prostate cancer under active surveillance.",{"count":385,"type":22},486,[25],"This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.",[32],{"date":366,"type":41},{"date":391,"type":41},"2026-04-23",{"date":393,"type":22},"2029-12",{"name":395,"class":94},"Inhibikase Therapeutics",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":224},"100581149","phase-2-a-trial-of-apl-9796-in-adults-with-pulmonary-hypertension-100581149","NCT06846554","A Trial of \"APL-9796'' in Adults With Pulmonary Hypertension","A Phase 2, Multicentre, Open-Label Trial to Evaluate APL-9796 in Adult Participants With Pulmonary Hypertension (ViTAL-PH)","ViTAL-PH","Inclusion Criteria:\n\n1. Participant must be 18 to 80 years of age inclusive\n2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.\n3. WHO Functional Class II or III\n4. Participant has the CardioMEMS PA Sensor implanted.\n\nExclusion Criteria:\n\n1. Hospital admission related to PH within 3 months prior to Screening.\n2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator\n3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease\n4. History of left-sided heart disease and\u002For clinically significant cardiac disease\n5. History of uncontrolled systemic hypertension\n6. eGFR ≤30 ml\u002Fmin\u002F1.73m2\n7. Life expectancy of \\\u003C 12 months, as assessed by the Investigator\n8. Diagnosed with a malignancy within 5 years of enrolment\n9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods",{"count":405,"type":22},48,[76],"The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796.\n\nThe trial will be conducted in two parts:\n\n* Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH).\n* Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).",[32],[174,410,411],"WHO group 3","WHO group 1 PH","2026-05-06",{"date":185,"type":41},{"date":415,"type":41},"2025-04-09",{"date":417,"type":22},"2027-09-30",{"name":419,"class":94},"Apollo Therapeutics Ltd",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":49},"100520208","phase-2-repurposing-valsartan-may-protect-against-pulmonary-hypertension-100520208","NCT06053580","Repurposing Valsartan May Protect Against Pulmonary Hypertension","REVAMP-PH","Inclusion Criteria:\n\n1. Male or female, age 18 to 80\n2. WHO Group 1 Pulmonary Arterial Hypertension\n3. NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)\n4. Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥25 mmHg, occlusion pressure of ≤15 mmHg, and resistance ≥ 3 wood units\n5. Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy\n6. Able to walk with\u002Fwithout a walking aid for a distance of at least 50 meters\n\nExclusion Criteria:\n\n1. Pregnant or lactating\n2. Non-group 1 pulmonary hypertension or veno-occlusive disease\n3. History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity or vital capacity of ≥ 60 %\n4. Has received or will receive an investigational drug, device, or study within 30 days or during the course of study\n5. ACE-inhibitor, ARB or ARNI use within 30 days of randomization.\n6. Left sided myocardial disease as evidenced by left ventricular ejection fraction \\\u003C 40%\n7. Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data\n8. Anticipated survival less than 1 year due to concomitant disease\n9. Allergy or angioedema with ACE-inhibitor use\n10. Potassium \\>5mEq\u002FL or sCr \\>2mg\u002FdL at screening\n11. SBP \\\u003C90mmHg at screening",{"count":428,"type":22},60,[76],"This is a Phase 2, single-center, randomized placebo controlled trial of valsartan (an angiotensin receptor blocker) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of valsartan.",[32,432,433,434],"Right Heart Failure","Right Ventricular Dysfunction","Pulmonary Vascular Disorder","2026-04-30",{"date":437,"type":41},"2026-05-04",{"date":439,"type":41},"2024-02-28",{"date":441,"type":22},"2027-07-01",{"name":443,"class":190},"University of Washington",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":49},"100262136","genes-associated-with-development-of-pulmonary-arterial-hypertension-in-patients-with-congenital-shunt-lesions-100262136","NCT02691689","Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Prospective, Monocentric Pilot Study for the Identification of Known or Novel Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions","Inclusion Criteria:\n\n* Previous diagnosis of secundum atrial septal defect (ASD) or ventricular septal defect (VSD), with or without repair\n* Development of PAH, defined as mean PAP ≥ 25 mmHg by right heart catheterization, in combination with a pulmonary wedge pressure of ≤ 15 mmHg and a PVR (pulmonary vascular resistance) of \\> 3 Wood units\n* Preferably, families with congenital shunt lesions (at least three family members affected with ASD or VSD) will be considered for inclusion\n\nExclusion Criteria:\n\n* Other congenital heart disease\n* Mental retardation\n* Dysmorphic characteristics\n* Chronic lung disease or total lung capacity \\\u003C 80% of predicted value\n* History of pulmonary embolism",{"count":452,"type":22},21,[359],"Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality.\n\nNext to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.",[456,32,457],"Heart Defects, Congenital","Genetic Testing","2026-04-27",{"date":460,"type":41},"2026-04-29",{"date":462,"type":41},"2015-11",{"date":347,"type":22},{"name":465,"class":190},"Universitaire Ziekenhuizen KU Leuven",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":221,"maxAge":222,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":487},"100484413","phase-2-study-to-evaluate-sotatercept-mk-7962-in-children-with-pulmonary-arterial-hypertension-pah-mk-7962-008-100484413","NCT05587712","Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)","A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care","MOONBEAM","Inclusion Criteria\n\n* Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes:\n* Idiopathic pulmonary arterial hypertension (IPAH)\n* Heritable PAH\n* Drug\u002Ftoxin-induced PAH\n* PAH associated with connective tissue disease\n* PAH-congenital heart disease (CHD) with shunt closure \\>6 months before Screening and subsequently confirmed by RHC before Screening\n* PAH with coincidental shunt.\n* Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids \\[including subcutaneous and intravenous\\])\n* If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention:\n* Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or\n* Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n* Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention\n* If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention\n* If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study intervention\n\nExclusion Criteria\n\n* History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and\u002For left heart failure (eg, restrictive or dilated cardiomyopathy)\n* Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and\u002For diaphragm\n* History of Eisenmenger syndrome, Potts shunt, or atrial septostomy\n* Unrepaired or residual cardiac shunt\n* Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and\u002For venous involvement\n* PAH associated with portal hypertension\n* Known visceral (lung, liver, or brain) arteriovenous malformation(s)\n* History of full or partial pneumonectomy\n* Untreated more than mild obstructive sleep apnea\n* History of known pericardial constriction\n* Family history of sudden cardiac death or long QT syndrome\n* Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening\n* Cerebrovascular accident within 3 months before Screening\n* Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients",{"count":475,"type":22},42,[76],"The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \\\u003C18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.",[32],"2026-04-16",{"date":481,"type":41},"2026-04-20",{"date":483,"type":41},"2023-01-19",{"date":485,"type":22},"2028-09-21",{"name":139,"class":94},35,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":505,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":49},"100628633","evolution-of-hypoxic-burden-and-sympatheticparasympathetic-balance-in-patients-with-pulmonary-hypertension-100628633","NCT07464184","Evolution of Hypoxic Burden and Sympathetic\u002FParasympathetic Balance in Patients With Pulmonary Hypertension","HRV&PH","Inclusion Criteria:\n\n* Patients over 18 years of age\n* With precapillary pulmonary hypertension confirmed by pulmonary artery catheterization\n* With an indication for pulmonary artery vasodilator treatment\n* Affiliation with a social security system\n* Women of childbearing age using effective\u002Fhighly effective contraception (see CTFG) (estrogen-progestogen or intrauterine device or tubal ligation) for 6 months and a negative urine pregnancy test at inclusion, for the duration of the study.\n* Postmenopausal women: confirmed diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)\n* Individuals who have read and understood the information letter and signed the consent form\n\nNon-Inclusion Criteria:\n\n* Treatment with non-invasive ventilation\n* Eisenmenger syndrome\n* Systemic scleroderma\n* Neurodegenerative disease other than isolated peripheral neuropathies.\n* Untreated and\u002For uncontrolled cardiac rhythm or conduction disorders, including permanent AF\n* Untreated coronary artery disease or diagnosis of myocardial infarction within the last six months\n* Pacemaker wearer\n* Pregnant or breastfeeding women, or women who are not using reliable contraception\n* Persons deprived of their liberty by administrative or judicial decision or persons under judicial protection\u002Fguardianship or curatorship\n* History of psychological or sensory illness or abnormality that may prevent the subject from fully understanding the conditions required for participation in the protocol or prevent them from giving their informed consent",{"count":428,"type":22},[359],"Background and Rationale:\n\nSleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min\u002Fh)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy.\n\nIn addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH.\n\nObjectives:\n\n1. To describe the evolution of nocturnal hypoxic burden over time in patients with precapillary pulmonary hypertension (at baseline, 12 months, and 24 months).\n2. To describe the longitudinal evolution of HRV parameters (RMSSD, LF\u002FHF ratio, HF) at baseline, 12 months, and 24 months.\n3. To evaluate cross-sectional correlations (at baseline, M12, and M24) between HRV parameters, hypoxic burden, oxygen desaturation, apnea-hypopnea index (AHI), and clinical status.\n4. To evaluate longitudinal correlations between changes in HRV parameters, hypoxic burden, desaturation, AHI, and clinical status between baseline and M12, and between baseline and M24.\n5. To assess the 2-year prognostic value of HRV parameters and hypoxic burden for adverse clinical outcomes.\n\nStudy Design and Population:\n\nThis is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included.\n\nParticipants will undergo full overnight polysomnography (PSG) at:\n\n* Baseline (inclusion)\n* 12 months (M12)\n* 24 months (M24) For incident cases, baseline PSG will be performed prior to initiation of vasodilator therapy. All patients will continue to receive standard-of-care management according to current European guidelines for pulmonary hypertension.\n\nDescriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.",[499,32,500,501,502,503,504],"Precapillary Pulmonary Hypertension","Sleep-disordered Breathing","Nocturnal Hypoxemia","Autonomic Nervous System Dysfunction","Heart Rate Variability (HRV)","Cardiovascular Risk",[506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522],"Precapillary pulmonary hypertension","Pulmonary arterial hypertension","Hypoxic burden","Nocturnal hypoxia","Polysomnography","Sleep-disordered breathing","Heart rate variability (HRV)","RMSSD","LF\u002FHF ratio","High frequency","Autonomic nervous system","Sympathetic activation","Parasympathetic tone","Risk stratification","Prognostic markers","Right heart failure","Apnea-Hypopnea Index (AHI)","2026-04-10",{"date":525,"type":41},"2026-04-15",{"date":527,"type":22},"2026-06-01",{"date":529,"type":22},"2030-01-01",{"name":531,"class":190},"University Hospital, Rouen",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":332,"sex":17,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":579},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","0 Years","20 Years",{"count":543,"type":22},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[546,32,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569],"Coronavirus Infection (COVID-19)","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":572,"type":41},"2026-04-06",{"date":574,"type":41},"2020-03-05",{"date":576,"type":22},"2027-07",{"name":578,"class":190},"Duke University",51,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":588,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":49},"100558310","mobile-health-intervention-to-improve-exercise-in-pediatric-ph-100558310","NCT06549452","Mobile Health Intervention to Improve Exercise in Pediatric PH","MhOVE-PPH Study: Mobile Health Intervention to Improve Exercise in Pediatric PH","MhOVE-PPH","Inclusion Criteria:\n\n* Adolescents between ages 10-21 years.\n* Diagnosed with WHO Group 1 PAH or WHO Group 4 PH (CTEPH)\n* WHO functional class I-III\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n\nExclusion Criteria:\n\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane\u002Fwalker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, or associated.\n* Functional class IV heart failure\n* Requirement of \\> 2 diuretic adjustment in the prior three months.\n* Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).\n* Involved in any other investigational intervention.","10 Years","21 Years",{"count":170,"type":22},[359],"Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.",[32],"2026-03-24",{"date":596,"type":41},"2026-03-27",{"date":598,"type":41},"2024-12-01",{"date":600,"type":22},"2030-11-01",{"name":213,"class":190},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":49},"100558682","phase-1-a-study-on-the-efficacy-and-safety-of-empagliflozin-in-the-treatment-of-pulmonary-arterial-hypertension-100558682","NCT06554301","A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n1. At least 18 years old.\n2. Sign the informed consent form.\n3. Subjects who are willing and able to comply with the requirements of prescribed visits, treatment plans, laboratory examinations and other research procedures.\n4. PAH with symptoms was initially diagnosed and belonged to one of the following subgroups:\n\n   A. Idiopathic pulmonary hypertension (IPAH); B. hereditary pulmonary hypertension (HPAH); C drug or toxin-induced PAH, based on previous exposure to drugs, chemicals or toxins, such as fenfluramine derivatives, other appetite suppressants, toxic rapeseed oil or L- tryptophan.\n\n   D. PAH is accompanied by:\n\n   A) connective tissue disease B) Congenital systemic-pulmonary shunt (surgical correction must be performed at least one year before screening, and there is no or no clinically insignificant systemic-pulmonary shunt \\[1.0≤ lung-systemic blood flow ratio (QP\u002FQS)≤1.5\\]), according to the opinion of the researcher.\n5. Received right heart catheterization (RHC) at the time of screening or within 5 years before screening (if RHC is not performed, it will be performed during screening), which is consistent with the diagnosis of PAH and meets all the following criteria:\n\n   A. mean pulmonary artery pressure (papm) \\> 20mmhg (at rest) B pulmonary arteriole wedge pressure (PAWP)≤15 mmHg (if reliable PAWP data cannot be obtained, left ventricular end diastolic pressure \\[LVEDP\\]≤15 mmHg).\n\n   C pulmonary vascular resistance (PVR) \\> 2.00 wood units (\\> 160 dynes\u002Fsec\u002Fcm5).\n6. There are symptoms of WHO\u002FNYHA FC Grade II or III.\n7. Stable PAH targeted background oral therapy. Subjects received endothelin receptor antagonist (ERA) and\u002For phosphodiesterase inhibitor type 5 (PDE5-I) or soluble guanylate cyclase (sGC) agonist. Stability was defined as no change in dose or regimen within 30 days before baseline and during the duration of the study.\n8. 6-minute walking distance (6 MWD) ≥ 150m.\n9. If the subject is taking concomitant drugs that can affect PAH (for example, calcium channel blockers, digoxin or L- arginine supplements), the dose must be kept stable for at least 30 days before the baseline visit and throughout the study.\n10. If there is the possibility of pregnancy, both male and female subjects should agree to use a highly effective contraceptive method during the whole study period (from informed consent to the end of follow-up).\n\nExclusion Criteria:\n\n* 1\\) Subjects shall not have the following three or more risk factors for left ventricular dysfunction: Body mass index (BMI)≥30 kg\u002Fm2 History of systemic hypertension\n\nThere is any of the following evidence to prove the history of major coronary artery disease:\n\nA coronary angiographic evidence of a history of myocardial infarction or percutaneous coronary intervention or coronary artery disease (at least one coronary artery stenosis \\> 50%); B. Positive results of exercise provocation test and image evidence; C. previous coronary artery bypass surgery; D. stable angina pectoris; 2) Pulmonary function tests (PFTs) conducted within 180 days before or during the screening showed mild or above lung diseases. Subjects who meet any of the following criteria will be excluded: A. forced expiratory volume in the first second (FEV1)\\<60% (expected value); or B total lung volume (TLC) \\< 60% of the estimated value. 3) The evidence of thromboembolic disease is confirmed by lung ventilation\u002Fperfusion (V\u002FQ) scanning or local standard diagnosis and treatment evaluation at the time of diagnosis or after diagnosis of PAH.\n\n4\\) Severe chronic liver disease (i.e. Child-pugh grade C), portal hypertension, cirrhosis or complications of cirrhosis\u002Fportal hypertension (e.g., history of varicose bleeding, history of hepatic encephalopathy).\n\n5\\) Confirm the active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV).\n\n6\\) Subjects whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level is more than or equal to 3 times the normal upper limit value (ULN) or whose total bilirubin is more than or equal to 2 times ULN at the time of screening.\n\n7\\) Chronic renal insufficiency at screening, which is defined as serum creatinine \\> 2.5 mg\u002FdL or requiring dialysis support.\n\n8\\) Hemoglobin concentration \\< 9 g\u002FdL during screening. 9) diabetes. 10) cardiac function grade IV (NYHA classification) 11) The subject has been treated with IV or SC prostacyclin pathway drugs (for example, epoprostol, triprostinil or iloprost) at any time before baseline (allowed to be used in pulmonary vasodilation test).\n\n12\\) The subject has pulmonary vein occlusion disease. 13) Diagnosed and\u002For treated with malignant tumor within 5 years before screening, but excluding localized non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or radical resection of cervical carcinoma in situ.\n\n14\\) At the time of screening, there was a history of alcohol or drug abuse within 6 months.\n\n15\\) Start the exercise-based cardiopulmonary rehabilitation program within 90 days of the screening period and\u002For during the study period.\n\n16\\) Participated in other interventional clinical studies within 30 days before screening. It is allowed to participate in registered or observational studies at the same time, as long as the subjects meet all other selection criteria and comply with all research process requirements.\n\n17\\) Any reason (for example, any past or intermittent diseases) that the respondent thinks may increase the risk of participating in the study or may affect the study analysis and damage the study participation or collaboration, so that the subject cannot participate in the study.\n\n18\\) Those who are known to be allergic to Engelgin or any auxiliary materials. 19) According to the researcher\\'s judgment, life expectancy is less than 12 months.\n\n20\\) Pregnant or lactating women.",{"count":609,"type":22},72,[75],"The goal of this clinical trial is to learn if empagliflozin works to treat patients with pulmonary arterial hypertension. It will also learn about the safety of empagliflozin. The main questions it aims to answer are:\n\nBased on standard treatment, does empagliflozin reduce pulmonary artery pressure and improve cardiac function in patients with pulmonary arterial hypertension? What medical problems do participants have when taking empagliflozin? Researchers will compare empagliflozin to a placebo (a look-alike substance that contains no drug) to see if empagliflozin works to treat patients with pulmonary arterial hypertension.\n\nParticipants will:\n\nTake empagliflozin or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the drug taking situation",[32],"2026-03-17",{"date":615,"type":41},"2026-03-19",{"date":617,"type":41},"2024-10-20",{"date":619,"type":22},"2026-12",{"name":621,"class":375},"China National Center for Cardiovascular Diseases",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":629,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100626866","phase-2-clinical-trial-of-ns-863-in-participants-with-pulmonary-arterial-hypertension-pah-100626866","NCT07441200","Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants With Pulmonary Arterial Hypertension (PAH)","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to participation in the trial, which includes the ability to comply with the requirements and restrictions listed in the informed consent form (ICF). Participants must be able to read, comprehend, and write at a level sufficient to complete trial-related materials\n* Adult male or female participants 18 to 75 years of age at the time the ICF is signed\n* Diagnosed with Group 1 PAH and pre-capillary PH defined by RHC during or at any time prior to the Screening Visit in any of the following subtypes:\n\n  1. Idiopathic PAH (IPAH)\n  2. Heritable PAH (HPAH)\n  3. PAH associated drug and toxins (DPAH)\n  4. PAH associated with connective tissue disease (PAH-CTD)\n  5. PAH associated with congenital heart disease (PAH-CHD); simple systemic to pulmonary shunt at least 6 months after surgical repair\n* Diagnosed as WHO FC II, III, or IV on stable background therapy\n* Results of the RHC within 35 days prior to Day 1 and meet all of the following criteria:\n\n  1. Participants receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, prostacyclin analogs or prostacyclin receptor agonists, calcium channel blocker, and\u002For diuretics are eligible only if on a stable dose for at least 90 days prior to RHC at baseline and throughout the Screening Period. For infusion prostacyclin analogs, dose adjustment based on the participant's body weight is allowed per medical practice. Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a preexistent oral diuretic to parenteral administration; however, dose adjustments (up or down) in preexistent oral diuretics are acceptable\n  2. Participants receiving treatment with activin-signaling inhibitor are eligible only if on a stable dose for at least 180 days prior to RHC at baseline and throughout the Screening Period. Dose adjustment based on the participant's body weight is allowed per medical practice.\n* Valid 6-minute walk distance (6MWD)\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test before receiving the trial treatment and must agree to use contraception from the Screening Visit to at least 30 days after the last dose of the trial treatment. Male participants who could potentially cause pregnancy must agree to use contraception from the Screening Visit to at least 90 days after the last dose of the trial treatment to avoid pregnancy in their partners\n* Able to complete the scheduled visits and follow the instructions of the investigator\n\nExclusion Criteria:\n\n* Current diagnosis of the following PAH Group 1 subtypes:\n\n  1. PAH associated with human immunodeficiency virus (HIV) infection\n  2. PAH associated with portal hypertension\n  3. PAH associated with schistosomiasis\n  4. PAH with features of venous\u002Fcapillary involvement\n  5. Eisenmenger syndrome and PAH associated with prevalent systemic to pulmonary shunts in PAH-CHD\n* Have ≥3 of the following LV disease\u002Fdysfunction risk factors. :\n\n  1. Body mass index (BMI) ≥30 kg\u002Fm2 at the Screening Visit\n  2. History of essential hypertension\n  3. Diabetes mellitus (any type)\n  4. Historical evidence of significant coronary artery disease\n* Diagnosis of PH Groups 2, 3, 4, or 5 of the classification\n* Moderate or severe obstructive lung disease (forced expiratory volume in one second \\[FEV1\\]\u002Fforced vital capacity \\[FVC\\] \\\u003C0.6) or restrictive lung disease (total lung capacity \\[TLC\\] \\\u003C70% of predicted value or lung diffusion capacity for carbon monoxide \\[DLco\\] \\\u003C45% except for PAH-systemic sclerosis) during the Screening Period.\n* Moderate or severe liver, renal, blood, or psychiatric disease:\n\n  1. Moderate and severe hepatic impairment by the Child-Pugh scoring system (Class B and Class C)\n  2. Moderate and severe renal impairment by estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002Fm2\n  3. Have mental disorders or other conditions that make it difficult to follow the protocol\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse disorder\n* History of calculus urinary\n* Initiation of pulmonary rehabilitation within 12 weeks prior to baseline\n* Have diseases or symptoms that limit evaluation of 6MWT\n* Life expectancy is less than 1 year\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the time of trial participation\n* Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with trial participation or trial treatment administration\n* Have a history of allergies to the excipients in the trial treatment\n* Known HIV positive status\n* Active hepatitis due to hepatitis B virus or hepatitis C virus\n* Use of any protocol prohibited medications\n* Receipt of any live vaccine within 4 weeks prior to the first dose of trial treatment or expected need for live vaccination during trial participation, including at least 4 weeks after the last dose of trial treatment\n* The investigator has judged the participant as unwilling or unable to comply with the protocol\n* Other concurrent disease and\u002For medical condition that, in the judgment of the investigator, may put the participant at risk or may influence the results of the trial or the participant's ability to complete the entire duration of the trial.",{"count":630,"type":22},135,[76],"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Trial to Evaluate the Efficacy and Safety of Orally Administered NS-863 in Participants with Pulmonary Arterial Hypertension (PAH)",[32],[32],"2026-02-24",{"date":637,"type":41},"2026-02-27",{"date":57,"type":22},{"date":640,"type":22},"2028-11-01",{"name":642,"class":94},"NS Pharma, Inc."]