[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-artery-hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-artery-hypertension":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,68,101,127,149,172],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100603743","phase-4-sotatercept-in-pulmonary-arterial-hypertension-100603743",false,"NCT07140484","Sotatercept in Pulmonary Arterial Hypertension","A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)","Eligible participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Age ≥ 18 years.\n2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of 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 CTD\n   * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair.\n3. Symptomatic PAH classified as WHO FC II or III.\n4. On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).\n5. Females of childbearing potential must:\n\n   * Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.\n   * If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.\n   * Refrain from breastfeeding a child or 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 treatment.\n6. Male participants must:\n\n   * Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.\n   * Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment\n7. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.\n8. Ability to understand and provide written informed consent.\n\nExclusion Criteria\n\n1. 1\\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5\n2. Musculoskeletal limitation that precludes participation in cycle ergometry\n3. Resting oxygen saturation \\\u003C 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).\n4. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.\n5. Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.\n6. Baseline platelet count \\\u003C 50,000\u002Fmm3 (\\\u003C 50.0 × 109\u002FL) in the enrollment period.\n7. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\> 160 mmHg or sitting diastolic blood pressure \\> 100 mmHg during a screening visit after a period of rest.\n8. Baseline systolic blood pressure \\\u003C 90 mmHg at screening.\n9. Pregnant or breastfeeding women.\n10. Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002Fm2 (as defined by the Modification of Diet in Renal Disease \\[MDRD\\] equation)\n    * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \\> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).\n11. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.\n12. History of full pneumonectomy.\n13. Pulmonary function test (PFT) values of forced vital capacity (FVC) \\\u003C 60% predicted and\u002For FEV1\u002FFVC \\\u003C lower limit of normal at the screening visit or within 6 months prior to the screening visit.\n14. Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.\n15. Body mass index ≥ 40 kg\u002Fm2.\n16. Planned initiation of an exercise program for cardiopulmonary rehabilitation 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).\n17. Known history of portal hypertension or chronic liver disease, including hepatitis B and\u002For hepatitis C (with evidence of recent infection and\u002For active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).\n18. History of restrictive, constrictive, or congestive cardiomyopathy.\n19. History of atrial septostomy within 180 days prior to the screening visit.\n20. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \\> 500 ms during the Screening Period\n21. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.\n22. Left ventricular ejection fraction \\\u003C 45% on historical echocardiogram within 6 months prior to the screening visit.\n23. Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.\n24. Cerebrovascular accident within 3 months prior to the Screening Visit.\n25. Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).\n26. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.\n27. Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.\n\nParticipants will be asked to:\n\n* Take Sotatercept every 21 days (±3 days)\n* Each participant will be enrolled in the study for 29 Weeks\n* Visit the clinic 18 times\n* Have a physical exam\n* Perform assessments of lung function and exercise tests\n* Have an ultrasound of their heart\n* Have blood draws done at regular intervals\n\nThe main objectives of the study are:\n\nPrimary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.\n\nSecondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.",[26],"Pulmonary Artery Hypertension",[28,29,30],"diffusing capacity","membrane diffusing capacity","pulmonary capillary blood volume","RECRUITING","2026-06-02",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":35},"2025-10-06",{"date":39,"type":20},"2030-01-01",{"name":41,"class":42},"University of Alberta","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100518847","endothelial-cell-activation-and-total-pulmonary-resistance-in-pah-100518847","NCT06035861","Endothelial Cell Activation and Total Pulmonary Resistance in PAH","Investigating the Relationship Between Endothelial Cell Activation and Total Pulmonary Resistance in Pulmonary Artery Hypertension (PAH)","Inclusion Criteria:\n\n1. Subjects aged between 18-75 years old\n2. PAH which is: idiopathic; PAH heritable; PAH associated with connective tissue disease; PAH after ≥ 1 year repair of congenital systemic to pulmonary shunt; or PAH associated with anorexignes or other drugs.\n3. Resting mean pulmonary artery pressure ≥25 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, PVR \\>5 wood units, and normal or reduced cardiac output, as measured by a previous right heart catheterisation (RHC).\n4. Have an insertable FDA\u002FCE cardiac rhythm monitor and pulmonary artery pressure monitor that captures cardiopulmonary haemodynamics and daily activity.\n5. Six-minute walking distance \\>50m at entry\n6. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed for PAH (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month prior to screening\n7. Subjects willing to be genotyped for genes that influence XBD173 activity\n8. Able to provide written informed consent prior to any study mandated procedures\n9. Contraception: Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill during treatment and until the end of relevant systemic exposure\n\nExclusion Criteria:\n\n1. Unable to provide informed consent and\u002For are non-fluent speakers of the English language\n2. Hypersensitivity to XBD173 or to any of the excipients\n3. Clinically-significant renal disease (confirmed by creatinine clearance \\\u003C30 ml\u002Fmin per 1.73m2)\n4. Clinically-significant liver disease (confirmed by serum transaminases \\>2 times than upper normal limit)\n5. Anaemia confirmed by haemoglobin concentration \\\u003C10 g\u002Fdl\n6. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia\n7. Hospital admission related to PAH or change in PAH therapy within 3 months prior to screening\n8. History of left-sided heart disease and\u002For clinically significant cardiac disease, including but not limited to any of the following:\n\n   1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis, moderate mitral regurgitation\n   2. Mechanical or bioprosthetic cardiac valve\n   3. Pericardial constriction, effusion with tamponade physiology, or abnormal left atrial size.\n   4. Restrictive or congestive cardiomyopathy\n   5. Left ventricular ejection fraction ≤50% (measured in echocardiogram at screening)\n   6. Symptomatic coronary disease\n   7. Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation\n   8. Acutely decompensated left heart failure within 1 month of screening\n   9. History of untreated obstructive sleep apnoea\n9. Evidence of significant lung disease on high-resolution CT (if available) or recent (performed within 12 months) lung function, where FEV1 \\\u003C 50% predicted and FVC \\\u003C 70% predicted, and DLCO (or TLCO) \\\u003C 50% predicted if any CT abnormalities; judged by the Site Physician\n10. Patients with a history of uncontrolled systemic hypertension\n11. Acute infection (including eye, dental, and skin infections)\n12. Chronic inflammatory disease including HIV, and Hepatitis B\n13. Women of childbearing potential who are pregnant or breastfeeding (if applicable)\n14. Patients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (which ever is greater) before the baseline visit","75 Years",{"count":53,"type":20},6,[55],"NA","To determine whether changes in endothelial cell dysfunction are associated with changes in total pulmonary resistance in patients with pulmonary arterial hypertension",[26],"NOT_YET_RECRUITING","2026-03-24",{"date":61,"type":35},"2026-03-25",{"date":63,"type":20},"2026-08-01",{"date":65,"type":20},"2026-10-31",{"name":67,"class":42},"Imperial College London",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100296428","fetal-endoscopic-tracheal-occlusion-for-congenital-diaphragmatic-hernia-feto-100296428","NCT03138863","Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)","Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863","FETO","Inclusion Criteria:\n\n* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks.\n* Isolated Left CDH with liver up\n* Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O\u002FE lung area to head circumference ratio (LHR) \\\u003C 25% (measured at 180 to 296 weeks) at the time of surgery; O\u002FE LHR 25% to \\\u003C30% (measured at 300 to 316 weeks) at time of surgery.\n* Gestational age at FETO procedure with O\u002FE LHR \\\u003C25% at 27 weeks 0 days to 29 weeks 6 days; with O\u002FE LHR 25% to \\\u003C30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound\n* Patient meets psychosocial criteria\n\nExclusion Criteria:\n\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Psychosocial ineligibility, precluding consent:\n* Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial\n* Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.\n* Right sided CDH or bilateral CDH, isolated left sided with O\u002FE LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound\n* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n* History of incompetent cervix with or without cerclage\n* Placental abnormalities (previa, abruption, accrete) known at time of enrollment\n* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy\n* Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy","FEMALE","50 Years",{"count":79,"type":20},10,[55],"The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).",[83,84,26],"Congenital Diaphragmatic Hernia","Pulmonary Hypoplasia",[86,87,88,89,90],"fetal lungs","fetal surgery","congenital diaphragmatic hernia","tracheal occlusion","pulmonary hypoplasia","2026-02-19",{"date":93,"type":35},"2026-02-23",{"date":95,"type":35},"2024-05-01",{"date":97,"type":20},"2030-11-01",{"name":99,"class":42},"Rodrigo Ruano",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":43},"100283215","phase-1--vascular-function-in-health-and-disease-100283215","NCT02966665",": Vascular Function in Health and Disease","Vascular Function in Health & Disease: Rehabilitation for Hypertension; Exercise and Skeletal Muscle Afferent Feedback","Inclusion Criteria:\n\n* Healthy Young Volunteers: 18-30 years of age with no diseases or conditions that would affect their participation in the study\n* Healthy Older Controls: volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study\n* Coronary Angiography subjects: patients undergoing routine coronary angiography\n* Chronic Obstructive Pulmonary Disease subjects: patients diagnosed with mild to moderate COPD\n* Pulmonary Arterial Hypertension subjects: patients with idiopathic or heritable Group 1 pulmonary arterial hypertension\n* Heart Failure subjects: patients with Class I, II or III New York Heart Association symptoms of Heart Failure\n* Hypertension subjects: patients diagnosed with chronic high blood pressure\n\nExclusion Criteria:\n\n* Severe COPD (use of supplemental oxygen, or have a one-second forced expiratory volume of less than 30% predicted)\n* History of myocardial infarction\n* History of percutaneous coronary revascularization\n* History of coronary artery bypass grafting\n* Unstable angina pectoris\n* History of variant angina\n* Ejection fraction \\\u003C 50%\n* Significant renal disease (Glomerular Filtration Rate \\\u003C 50 mL\u002Fmin\u002F1.73m2)\n* Subjects whose medical care or safety may be at risk from undergoing a Magnetic Resonance Imaging examination (e.g. pacemaker, metal implants, certain types of heart valves)\n* Subject is pregnant\n* Subject has physical ailments (other than COPD, PAH, HF, or hypertension) that would prevent them from study participation in the judgment of the investigator",true,{"count":110,"type":20},420,[112],"PHASE1","Many control mechanisms exist which successfully match the supply of blood with the metabolic demand of various tissues under wide-ranging conditions. One primary regulator of vasomotion and thus perfusion to the muscle tissue is the host of chemical factors originating from the vascular endothelium and the muscle tissue, which collectively sets the level of vascular tone. With advancing age and in many disease states, deleterious adaptations in the production and sensitivity of these vasodilator and vasoconstrictor substances may be observed, leading to a reduction in skeletal muscle blood flow and compromised perfusion to the muscle tissue. Adequate perfusion is particularly important during exercise to meet the increased metabolic demand of the exercising tissue, and thus any condition that reduces tissue perfusion may limit the capacity for physical activity. As it is now well established that regular physical activity is a key component in maintaining cardiovascular health with advancing age, there is a clear need for further studies in populations where vascular dysfunction is compromised, with the goal of identifying the mechanisms responsible for the dysfunction and exploring whether these maladaptations may be remediable. Thus, to better understand the etiology of these vascular adaptations in health and disease, the current proposal is designed to study changes in vascular function with advancing age, and also examine peripheral vascular changes in patients suffering from chronic obstructive pulmonary disease (COPD), Sepsis, Pulmonary Hypertension, and cardiovascular disease. While there are clearly a host of vasoactive substances which collectively act to govern vasoconstriction both at rest and during exercise, four specific pathways that may be implicated have been identified in these populations: Angiotensin-II (ANG-II), Endothelin-1 (ET-1), Nitric Oxide (NO), and oxidative stress.",[115,26,116,117],"Chronic Obstructive Pulmonary Disease","Heart Failure","Hypertension","2025-09-22",{"date":120,"type":35},"2025-09-26",{"date":122,"type":4},"2008-09",{"date":124,"type":20},"2026-08",{"name":126,"class":42},"Russell Richardson",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":43},"100557902","non-invasive-measurements-of-changes-in-pulmonary-artery-pressure-in-intensive-care-unit-patients-using-electrical-impedance-tomography---a-feasibility-study-100557902","NCT06544148","Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study","Non-Invasive Measurements of Changes in Pulmonary Artery Pressure in Intensive Care Unit Patients Using Electrical Impedance Tomography - A Feasibility Study (PAP-EIT Study)","PAP-EIT","Inclusion criteria:\n\n* Age ≥ 18-year-old.\n* Intubated patients in the ICU with clinical decision to monitor PAP and cardiac output using a PAC.\n\nExclusion criteria:\n\n* Patients with implanted or external thoracic electronic devices (e.g., pacemaker) or thoracic metal implants.\n* Known pregnancy or lactating patients.\n* Open lung injuries or pneumothorax.\n* Open wounds, drainages, burns or rashes of the upper thorax.\n* Estimated thoracic perimeter smaller than 66 cm or larger than 134 cm.\n* Known allergies to wound dressings or adhesives (e.g., gel electrodes)",{"count":136,"type":20},28,"OBSERVATIONAL","To assess whether changes in electrical impedance - measured using an electrical impedance tomography (EIT) chest belt - can be used to derive changes in pulmonary artery pressure (PAP) in critically ill patients when compared to invasive gold-standard PAP measured using pulmonary artery catheter (PAC).",[26],"2024-11-12",{"date":142,"type":35},"2024-11-14",{"date":144,"type":35},"2024-08-05",{"date":146,"type":20},"2027-08-05",{"name":148,"class":42},"Insel Gruppe AG, University Hospital Bern",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":17,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":43},"100549097","potts-shunt-for-the-treatment-of-pediatric-patients-with-severe-pulmonary-hypertension-100549097","NCT06429579","Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension","Multicenter, Prospective, and Exploratory Study of Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension","Inclusion Criteria:\n\n1. 6 months \\< age ≤ 18 years;\n2. ESC 2022 Group I PAH;\n3. Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high\u002Fhigh-risk status of the criteria of ESC2022;\n4. Presenting with significant clinical manifestations (i.e., progressive symptoms\u002Fsyncope history\u002Fgrowth and development restriction, etc);\n5. Informed consent form signed by the patient and their guardian.\n\nExclusion Criteria:\n\n1. ESC 2022 Group II-V PAH;\n2. Poor right ventricular function: RVEF \\< 25% or RVFAC \\< 20%;\n3. Deteriorated general condition: requiring ICU resuscitation or ECMO assistance;\n4. Pulmonary artery pressure\u002Fmain arterial pressure ratio \\< 0.7;\n5. Six-minute walk distance \\< 150 meters (only applicable to patients aged 8 and above);\n6. No significant improvement in RVEF under triple drug therapy.","6 Months",{"count":158,"type":20},120,[55],"This is a multi-center, perspective, and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension (PAH). The included criteria are as followed: 1)6 months \\\u003C age ≤ 18 years; 2) ESC 2022 Group I PAH; 3) Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high\u002Fhigh-risk status of the criteria of ESC2022; 4) Presenting with significant clinical manifestations (i.e., progressive symptoms\u002Fsyncope history\u002Fgrowth and development restriction, etc); 5) Informed consent form signed by the patient and their guardian. The excluded criteria are as followed: 1) ESC 2022 Group II-V PAH; 2) Poor right ventricular function: RVEF \\\u003C 25% or RVFAC \\\u003C 20%; 3) Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4) Pulmonary artery pressure\u002Fmain arterial pressure ratio \\\u003C 0.7; 5) Six-minute walk distance \\\u003C 150 meters (only applicable to patients aged 8 and above); 6) No significant improvement in RVEF under triple drug therapy. All of the pediatric patients with severe PAH who attend to pediatric cardiac outpatient clinic and meet the designed included criteria and excluded criteria will be enrolled in this study. All of the participants will be divided into two groups (Potts-shunt combined with conventional drug therapy group and only conventional drug therapy group) according to their individual health status (i.e., some contraindications of surgery) and their (or their parents') aspiration for Potts-shunts procedure. Follow-up is designed (eight-times follow-up) at the time of Potts-shunt procedure, post-operative ICU period, one month, three months, six months, one year, two years, and three years after Potts-shunt procedure or the rejection of Potts-shunt procedure. The items of follow-up include state of survival, whether or not have the lung transplantation (LTx), clinical manifestation, laboratory examination, function of right ventricle (detected by echocardiogram and cardiac magnetic resonance imaging), and the pulmonary circulation pressure (detected by right heart catheterization or Swan-Ganz catheterization). Primary outcome is the incidence rates of death or LTx three-years after Potts-shunt. Secondary outcomes are as followed: 1) Number and incidence rate of postoperative complications in patients undergoing Potts-shunt procedure; 2) Three-year WHO cardiac functional and 6-minute walk distance after Potts-shunt procedure; 3) the NT-ProBNP levels three-years after Potts-shunt procedure; 4) Right ventricular function on echocardiography three years after Potts-shunt procedure; 5) Right ventricular function on cardiac magnetic resonance imaging three years after Potts-shunt procedure; 6) Pulmonary circulation pressure measured by right heart catheterization or Swan-Ganz catheterization three years after Potts-shunt procedure; 7) Three-year mortality or LTx incidence rates after only conventional drug therapy.",[26],"2024-05-23",{"date":164,"type":35},"2024-05-28",{"date":166,"type":35},"2024-04-23",{"date":168,"type":20},"2029-04-23",{"name":170,"class":171},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100535978","phase-4-restoration-of-vitamin-d-in-pulmonary-arterial-hypertension-100535978","NCT06258850","REstoration of VItamin D in Pulmonary Arterial Hypertension","REstoration With Calcifediol of VItamin D Deficiency in Pulmonary Arterial Hypertension Patients","REVIDAH","Inclusion Criteria:\n\n1. Male and female patients aged 18 -75 years.\n2. Patients with diagnosis of PAH of the following types according to 2022 ERS\u002FESC guidelines: idiopathic, hereditary, drug and toxin-induced PAH or associated to connective tissues disease.\n3. Patients who are stable and treated with standard medications for PAH on monotherapy or with combinations of drugs, including calcium channel blockers, phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERA), prostacyclin analogues or selexipag or with stable dose of diuretics who had no treatment modification for at least 6 weeks before randomization.\n4. Patients with an intermediate-low and intermediate-high risk score according to 2022 ERS\u002FESC guidelines.\n5. Patients with severe deficiency of vitamin D, defined herein as plasma or serum 25(OH)vitamin D levels equal to or lower than 12 ng\u002Fml\n6. Patients who can understand and follow instructions, and who are able to participate in the study for the entire study.\n7. Patients must have given their written informed consent to participate in the study after having received adequate previous information and before any study-specific procedures.\n\nExclusion Criteria:\n\n1. Participation in another interventional clinical study within 30 days before screening.\n2. Previous randomisation to treatment during this study (no re-randomisation).\n3. Pregnant women or breastfeeding women, or women with childbearing potential not using a effective contraception method throughout the study.\n4. Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate in or complete this study, in the opinion of the investigator.\n5. Patients with substance abuse (eg, alcohol or drug abuse) within the previous 3 months before and at randomisation.\n6. Patients with underlying medical disorders with an anticipated life expectancy \\\u003C2 years.\n7. Patients with a history of severe allergies or multiple drug allergies or with hypersensitivity to the investigational drug or any of the excipients.\n8. Patients unable to perform a valid 6MWD test (eg, orthopaedic disease or peripheral artery occlusive disease that affects the patient's ability to walk).\n9. Excluded medication\u002Ftreatment: active treatment with digoxin.",{"count":181,"type":20},102,[23],"Background. Pulmonary arterial hypertension (PAH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation. The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Moreover, vitamin D deficiency has a negative prognostic impact in PAH. Animal studies support that vitamin D deficiency worsens PAH.\n\nHypothesis. In patients with PAH and vitamin D deficiency, restoration of vitamin D status with calcifediol improves their symptomatology and prognosis.\n\nDesign: Multicenter clinical trial with the participation of 9 hospitals, placebo-controlled, randomized (1:1 ratio), in two parallel groups (without crossover), triple blind, and add-on on existing treatments (add-on). It will include at least 102 subjects (51 in the calcifediol group and 51 in the placebo group) followed for 24 weeks of treatment.\n\nInclusion criteria: Patients of both sexes (18-75 years) with hemodynamic diagnosis of PAH and severe vitamin D deficiency (25-OHvitD \\\u003C= 12 ng\u002Fml) and without previous diagnosis of osteoporosis or osteomalacia.\n\nTreatments: 1) Calcifediol Hydroferol® 0.266 mg once every 10 days for the first 12 weeks and once every two weeks for the following 12 weeks. 2) Placebo.\n\nMain objective: A composite endpoint of clinical improvement without clinical worsening at week 24.\n\nExpected outcome: Restoration of vitamin D status is an unexpensive measure, very easily implantable and that could improve the evolution of the disease as well as other aspects such as bone or immune health and that has few side effects.",[26,185],"Vitamin d Deficiency",[187,188],"Clinical improvement","Clinical worsening","2024-02-06",{"date":191,"type":35},"2024-02-14",{"date":193,"type":20},"2024-07-01",{"date":195,"type":20},"2027-12",{"name":197,"class":42},"Parc de Salut Mar"]