[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-arterial-hypertension-of-congenital-heart-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-arterial-hypertension-of-congenital-heart-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100620373","phase-4-a-study-of-sotatercept-for-patients-with-eisenmenger-syndrome-or-unrepaired-shunt-associated-pulmonary-arterial-hypertension-resistant-to-vasodilator-therapy-100620373",false,"NCT07356778","A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy","An Open-label, Randomized, Controlled Trial to Evaluate the Efficacy of Sotatercept Add-on Therapy Compared to Standard PAH Therapy With Pulmonary Vasodilators for Pulmonary Arterial Hypertension Associated With Pulmonary Vasodilator-resistant, Unrepaired Congenital Shunts (ASD, VSD, PDA) Including Eisenmenger Syndrome：SuMILE Trial","SuMILE","Inclusion Criteria:\n\n* adults (≥18 years)\n* unrepaired ASD, VSD or PDA\n* ≥90 days of pulmonary vasodilator therapy; and either (i) pulmonary vascular resistance (PVR) ≥5 Wood units and mean pulmonary arterial pressure (mPAP) \\> 20 mm Hg on right heart catheterization within 180 days, or (ii) echocardiographic tricuspid regurgitation velocity \\>3.4 m\u002Fs with right-to-left\u002Fbidirectional shunt plus resting SpO₂ ≤92% consistent with cyanosis\n* baseline 6MWD ≥100 m\n* ability to complete questionnaires\n\nExclusion Criteria:\n\n* WHO functional class IV; other unrepaired intracardiac shunts\n* severe renal\u002Fhepatic\u002Fparenchymal lung disease or LVEF \\\u003C40%\n* prior sotatercept use\n* contraindication to sotatercept per label\n* investigator-judged unsuitability","ALL","18 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","What is this study about? This study will test whether adding sotatercept to usual medicines for pulmonary arterial hypertension (PAH) can help adults who have PAH due to unrepaired congenital heart defects (atrial or ventricular septal defect, or patent ductus arteriosus), including Eisenmenger syndrome. These conditions often cause long-standing changes in the lung blood vessels and low oxygen levels.\n\nWho can join? About 36 adults (age ≥18 years) in Japan whose PAH has not improved enough with pulmonary vasodilators may join. People with very severe symptoms (WHO class IV) or other serious illnesses will not be enrolled.\n\nWhat will happen if I join?\n\nParticipants will be randomly assigned (like a coin flip, in a 2:1 ratio) to:\n\nSotatercept + vasodilator-based PAH care, or\n\nvasodilator-based PAH care alone. The study lasts 24 weeks. Those who receive sotatercept will have injections every 3 weeks. All participants will have clinic visits and tests at the start, week 12, and week 24, including a 6-minute walk test (how far you can walk in 6 minutes), blood tests, questionnaires, and other heart-lung assessments used in routine PAH care.\n\nWhat are the possible benefits? Sotatercept improved exercise capacity and heart-lung measures in other PAH studies, but people with unrepaired heart defects were not included. This study may or may not help you directly, but it may help doctors learn how to use sotatercept safely in this group.\n\nWhat are the possible risks? Side effects seen with sotatercept include increase in haemoglobin, low platelets, nosebleeds, telangiectasia (small dilated blood vessels), bleeding, and blood clots. People with Eisenmenger syndrome can have both bleeding (for example, haemoptysis) and clotting risks. The study will check complete blood counts (CBC) regularly and adjust or pause dosing using label-based rules. Other risks are those of standard PAH care and blood tests.\n\nTime and location The study is conducted at multiple hospitals in Japan. Study participation lasts about 6 months.\n\nCosts and payments The study drug and study-specific tests will be provided at no cost. Usual medical care not required by the study will follow each hospital's standard billing. There is no required payment to join. Any travel reimbursement or stipends will follow site policy.\n\nPrivacy Your information will be kept confidential. Results will be shared in journals and at meetings without using your name.\n\nWho to contact If you are interested or have questions, please contact the study team at the participating hospital.",[27,28],"Eisenmenger Syndrome","Pulmonary Arterial Hypertension of Congenital Heart Disease",[30,31,32,33],"Eisenmenger syndrome","pulmonary arterial hypertension","Congential heart disease","sotatercept","RECRUITING","2026-01-20",{"date":37,"type":38},"2026-01-21","ACTUAL",{"date":40,"type":38},"2025-10-07",{"date":42,"type":21},"2028-04-30",{"name":44,"class":45},"Kazuya Hosokawa","OTHER",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100609664","rutgers-university-study-of-the-genetics-of-pulmonary-hypertension-100609664","NCT07217522","Rutgers University Study of the Genetics of Pulmonary Hypertension","RUGCC-PH","Inclusion Criteria:\n\n* age 18 years or older\n* currently living in the United States\n* able to understand and follow written instructions in English\n* have access to the internet and a computer, laptop, tablet or smart phone\n* willing to provide written informed consent for participation\n* willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home\n* willing to complete a survey with questions about health related to the study of pulmonary hypertension.\n\nExclusion Criteria:\n\n* Age 17 or below\n* Not currently living in the United States\n* Not able to participate in an online research study in English",true,{"count":56,"type":21},10000,"OBSERVATIONAL","The goal of this observational study is to learn more about how genes impact the risk of pulmonary hypertension. Anyone 18 or older living in the US is eligible, and a diagnosis of PH is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.",[60,61,62,63,64,65,28,66],"Pulmonary Hypertension","Pulmonary Arterial Hypertension","Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)","Pulmonary Arterial Hypertension Associated With Connective Tissue Disease","Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)","Pulmonary Arterial Hypertension Associated With Schistosomiasis (Disorder)","Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension","2025-10-30",{"date":69,"type":38},"2025-11-03",{"date":71,"type":38},"2025-08-23",{"date":73,"type":21},"2027-12-31",{"name":75,"class":45},"Rutgers, The State University of New Jersey",1]