[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pah\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pah":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100053832","impact-of-an-optimized-omega-3-formulation-on-inflammation-and-endothelial-dysfunction-in-pulmonary-arterial-hypertension-100053832",false,"NCT07697235","Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension","OMEGA-PAH","Inclusion Criteria:\n\n* Men or women between the ages of 18 and 75;\n* Idiopathic, hereditary, drug-induced, or anorexigen-induced PAH, or PAH associated with connective tissue disease;\n* Stable PAH treatment for at least 90 days;\n* Subjects capable of understanding the objectives and risks associated with the study and of providing dated and signed informed consent;\n* Subjects enrolled in a health insurance plan;\n* Subjects who have signed an informed consent form;\n* For women of childbearing age: negative pregnancy test at the screening\u002Finclusion visit; effective contraception\\* throughout the study (recommended in PAH)\n\n  * Effective and accepted methods of contraception during the study (subject, partner): oral contraceptive pill, intrauterine device (IUD), condom (male or female). Patients who practice total abstinence do not need to use contraception.\n\nExclusion criteria:\n\n* Patients treated with Omacor®;\n* Daily consumption of fish oil or fish oil-based dietary supplements (omega-3);\n* Hypersensitivity or allergy to fish, shellfish, peanuts, soy, corn oil, or coconut oil;\n* Anticoagulant therapy at therapeutic doses;\n* Cardiac decompensation within the month prior to enrollment;\n* Other causes of pulmonary hypertension (groups 2, 3, 4, or 5);\n* Persistent atrial fibrillation (AF);\n* Left ventricular ejection fraction \\\u003C 45% on echocardiography;\n* Recent episode of pulmonary embolism, within the past 6 months;\n* Myocardial infarction or placement of a coronary stent within the month prior to enrollment;\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²;\n* Malignant disease (not considered in remission);\n* Severe sepsis;\n* Participation in another clinical trial within the previous 3 months;\n* Subjects under legal guardianship, conservatorship, or curatorship","ALL","18 Years","75 Years",{"count":20,"type":21},22,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this research project is to evaluate the biological effects of long-chain omega-3 supplementation, administered in an optimized, high-purity formulation (EPA:DHA 6:1, \\>95% v\u002Fv), as an adjunct to standard-of-care treatment in patients with pulmonary arterial hypertension (PAH).\n\nThe expected results are confirmation in humans of our preliminary data, namely a beneficial effect on systemic inflammation and pulmonary endothelial dysfunction in PAH. If our hypothesis is confirmed, omega-3s could constitute a complementary nutritional approach to current PAH therapies, subsequently requiring validation through a larger-scale, randomized, controlled study.",[27],"PAH",[29,30,31,32],"pulmonary arterial hypertension","inflammation","peripheral circulating cells","omega-3","NOT_YET_RECRUITING","2026-07-08",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2030-03",{"name":43,"class":44},"University Hospital, Strasbourg, France","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100631294","phase-2-sota-es---sotatercept-in-patients-with-congenital-heart-disease-and-eisenmengers-syndrome-100631294","NCT07498803","Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome","CHASE","Inclusion Criteria:\n\n* Age ≥18 years\n* Congenital heart disease with Eisenmenger syndrome (known unrepaired atrial septal defect, and\u002For ventricular septal defect, and\u002For patent ductus arteriosus; patients with anomalous pulmonary venous drainage will not be considered)\n* Eisenmenger syndrome defined as right-to-left or bi-directional shunt with a mPAP \\>25 mmHg, PAWP \\\u003C 15 mmHg, and PVR \\>5 WU\n* In patients with pre-tricuspid shunt, the consideration of Eisenmenger syndrome requires one of the following: Systemic arterial O2 saturation (SaO2) at rest \\\u003C88% and more than 70%, and\u002For SaO2 \\\u003C80% during 6MWT, and secondary erythrocytosis (Hb \\> 15.0 g\u002Fdl for females and 16.0 g\u002Fdl for males)\n* On stable doses of background PAH therapy\\* and diuretics (i.e., patient-individual dose goal for each therapy achieved) for ≥30 days\n* 6-minute walking distance \\>100 m\n* WHO-FC II or III\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n\n  * Diagnosis of pulmonary hypertension groups 2, 3, 4, or 5\n  * Hospitalization or change in PAH background therapies within 30 days prior to screening (changes in dose of diuretics or parenteral prostanoids \\[\\\u003C10% change in infusion rate over the preceding 3 months\\] are allowed)\n  * Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\>160 mmHg or sitting diastolic blood pressure \\>100 mmHg during screening visit after a period of rest\n  * Baseline systolic blood pressure \\\u003C90 mmHg at screening\n  * Left ventricular systolic dysfunction (LVEF 40%)\n  * Restrictive lung disease with a TLC \\\u003C 60% AND demonstration of more than mild fibrosis on chest CT prior to enrolment (note that patients with congenital heart disease may have thoracic cage deformities \\[e.g. pectus\\] that may lead to thoracic cage restriction in the absence of parenchymal lung disease).\n  * Obstructive lung disease (FEV1 \\\u003C 60% pred. and FEV1\u002FFVC \\\u003C60%)\n  * Chronic thromboembolic disease (intermediate or high probability) on V\u002FQ scan and evidence of distal thromboembolism on CT angiography (note that proximal in-situ thrombosis is a known complication of Eisenmenger's and will not be considered an exclusion criterion - such patients may be reviewed centrally for inclusion)\n  * Significant liver disease (Child II or III)\n  * Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\\u003C30 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)\n  * Baseline platelet count \\\u003C50,000\u002Fµl (\\\u003C50.0 x 109\u002FL) at screening\n  * Documented episodes of previous repetitive hyperviscosity syndrome\n  * History of haemoptysis within 12 months prior to screening, and\u002For repeated severe epistaxis (≥ 1 episode per month)\n  * Uncorrected iron deficiency (iron stores must be normal defined as a Ferritin \\> 100 and transferrin saturation \\[TSAT\\] ≥ 20%)\n  * Recent (\\\u003C 3 months) enrolment into a rehabilitation program\n  * Untreated sleep disordered breathing with an AHI \\> 10. Patients with sleep apnea will need to have been on CPAP or BiPAP for 3 months prior to enrolment.\n  * Prior or current exposure to sotatercept or luspatercept\n  * Treatment by phlebotomy within 1 month prior to screening\n  * Participation in another interventional study\n  * Pregnant (serum B-HCG) or lactating women",{"count":54,"type":21},40,[56],"PHASE2","The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.\n\nCHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.",[59,60,27],"Congenital Heart Disease (CHD)","Eisenmenger Syndrome",[62,63,64],"Congenital heart disease with Eisenmenger syndrome","WHO-FC II or III","PAH therapy","2026-03-23",{"date":67,"type":37},"2026-03-27",{"date":69,"type":21},"2026-09-01",{"date":71,"type":21},"2028-12-31",{"name":73,"class":44},"Philipps University Marburg",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100590896","effects-of-pulmonary-rehabilitation-on-quality-of-life-and-health-in-pulmonary-arterial-hypertension-patients-100590896","NCT06973382","Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients","Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension","EPRQoL-PAH","Inclusion Criteria:Confirmed PH Diagnosis:\n\nRight heart catheterization-confirmed pulmonary hypertension\n\nMeets 2022 ESC\u002FERS Guidelines diagnostic criteria for:\n\n* Group 1 (PAH) or\n* Group 4 (CTEPH\u002Fother pulmonary artery obstructions)\n\nStabilized Treatment Status:\n\nGroup 1 (PAH): Received ≥3 months of targeted drug therapy\n\nGroup 4 (CTEPH): Completed ≥6 sessions of BPA\\* or reached therapeutic endpoint\n\nFunctional Capacity:\n\nWHO Functional Class I-III\n\nAge: ≥18 years\n\nConsent: Willing to provide written informed consent -\n\nExclusion Criteria:Physical Limitations:\n\nUnable to perform pulmonary rehabilitation exercises due to disability or congenital malformations\n\nCardiopulmonary Testing Contraindications:\n\nMedically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation\n\nPoor Compliance:\n\nHistory of non-adherence making protocol completion unlikely\n\nLife Expectancy:\n\nPrognosis ≤1 year\n\n\\-",{"count":83,"type":21},84,[24],"Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC\u002FERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.",[27,87],"CTEPH","2025-05-14",{"date":90,"type":37},"2025-05-15",{"date":92,"type":21},"2025-05-20",{"date":94,"type":21},"2027-10-31",{"name":96,"class":44},"Beijing Chao Yang Hospital"]