[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620373":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":180,"collaborators":11,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":11,"enrollmentInfo":193,"targetDuration":11,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"Kyushu University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sotatercept add-on + vasodilator-based PAH therapy","EXPERIMENTAL",null,[13,14],"Drug: Sotatercept","Drug: vasodilator-based PAH therapy",{"label":16,"type":17,"description":11,"interventionNames":18},"vasodilator-based PAH therapy alone","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Sotatercept","Sotatercept will be administered subcutaneously every 3 weeks for 24 weeks (total 8 injections): 0.3 mg\u002Fkg lead-in at Visit 1, then 0.7 mg\u002Fkg from Visit 2 if safety criteria are met. Dose holds\u002Freductions follow label-concordant rules based on complete blood count (CBC) prior to each dose (e.g., hemoglobin rise \\>4.0 g\u002FdL from baseline; or \\>2.0 g\u002FdL from the previous dose and above ULN; or \\>2.0 g\u002FdL above ULN; and platelet count \\\u003C50,000\u002FµL). Participants continue stable background PAH therapy (endothelin, nitric-oxide, prostacyclin pathways) per protocol; initiation or up-titration of PAH drugs during the 24-week treatment period is generally not permitted unless clinically mandated for safety and recorded as a protocol deviation.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"vasodilator-based PAH therapy","Participants receive no sotatercept. They continue site-standard, stable PAH therapy for 24 weeks (endothelin receptor antagonist, PDE5 inhibitor\u002Friociguat, and\u002For prostacyclin class as clinically indicated). Changes to background therapy are discouraged during the 24-week period unless required for safety; any changes are captured for analysis. The same visit schedule and assessments (e.g., 6-minute walk test, biomarkers, clinical events) apply as in the sotatercept arm.",[9,16],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Kazuya Hosokawa, MD, PhD","CONTACT","+81-92-642-5360","hosokawa.kazuya.712@m.kyushu-u.ac.jp",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Keimei Yoshida, MD, PhD","yoshida.keimei.713@m.kyushu-u.ac.jp",[39,64,75,89,103,117,131,145,159,170],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Kyushu University Hospital","RECRUITING","Fukuoka","Not Required For This Country","8150014","Japan","JP",{"type":48,"coordinates":49},"Point",[50,51],130.41667,33.6,{"lat":51,"lon":50},[54,57,60,62],{"name":55,"role":32,"phone":56,"phoneExt":11,"email":34},"Kazuya Hosokawa","+81-92-642-1151",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},"Ayako Ishikita","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":11,"phoneExt":11,"email":11},"Keimei Yoshida",{"name":55,"role":63,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":65,"status":41,"city":42,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"The Second Department of Internal Medicine, University of Occupational and Environmental Health",{"type":48,"coordinates":67},[50,51],{"lat":51,"lon":50},[70,74],{"name":71,"role":32,"phone":72,"phoneExt":11,"email":73},"Masaharu Kataoka","+81--603-1611","mkataoka@med.uoeh-u.ac.jp",{"name":71,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":76,"status":41,"city":77,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Division of Cardiovascular Medicine, Kobe University Hospital","Kobe",{"type":48,"coordinates":79},[80,81],135.183,34.6913,{"lat":81,"lon":80},[84,88],{"name":85,"role":32,"phone":86,"phoneExt":11,"email":87},"Yu Taniguchi","+81-78-382-5111","yu.taniguchi007@gmail.com",{"name":85,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":90,"status":41,"city":91,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine","Kyoto",{"type":48,"coordinates":93},[94,95],135.75385,35.02107,{"lat":95,"lon":94},[98,102],{"name":99,"role":32,"phone":100,"phoneExt":11,"email":101},"Naohiko Nakanishi","+81-75-703-5101","naka-nao@koto.kpu-m.ac.jp",{"name":99,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":104,"status":41,"city":105,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Department of Cardiology, Nagoya University Hospital","Nagoya",{"type":48,"coordinates":107},[108,109],136.90641,35.18147,{"lat":109,"lon":108},[112,116],{"name":113,"role":32,"phone":114,"phoneExt":11,"email":115},"Shiro Adachi","+81-52-741-2111","adachi.shiro.b6@f.mail.nagoya-u.ac.jp",{"name":113,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":118,"status":41,"city":119,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Department of Cardiovascular Medicine, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University","Okayama",{"type":48,"coordinates":121},[122,123],133.93333,34.65,{"lat":123,"lon":122},[126,130],{"name":127,"role":32,"phone":128,"phoneExt":11,"email":129},"Satoshi Akagi","+81-86-223-7151","akagi-s@cc.okayama-u.ac.jp",{"name":127,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":132,"status":41,"city":133,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine","Sendai",{"type":48,"coordinates":135},[136,137],140.86667,38.26667,{"lat":137,"lon":136},[140,144],{"name":141,"role":32,"phone":142,"phoneExt":11,"email":143},"Taijyu Sato","+81-22-717-7000","s-taiju@cardio.med.tohoku.ac.jp",{"name":141,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":146,"status":41,"city":147,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Department of Cardiology, Keio University School of Medicine","Tokyo",{"type":48,"coordinates":149},[150,151],139.69171,35.6895,{"lat":151,"lon":150},[154,158],{"name":155,"role":32,"phone":156,"phoneExt":11,"email":157},"Takahiro Hiraide","+81-3-3353-1211","t.hiraide.a6@keio.jp",{"name":155,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":160,"status":41,"city":147,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Department of Cardiovascular Medicine, Kyorin University School of Medicine",{"type":48,"coordinates":162},[150,151],{"lat":151,"lon":150},[165,169],{"name":166,"role":32,"phone":167,"phoneExt":11,"email":168},"Takumi Inami","+81-22-47-5511","tinami@ks.kyorin-u.ac.jp",{"name":166,"role":63,"phone":11,"phoneExt":11,"email":11},{"facility":171,"status":41,"city":147,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University Graduate School of Medicine",{"type":48,"coordinates":173},[150,151],{"lat":151,"lon":150},[176,179],{"name":177,"role":32,"phone":11,"phoneExt":11,"email":178},"Toshiro Shinke","shinke@med.showa-u.ac.jp",{"name":177,"role":63,"phone":11,"phoneExt":11,"email":11},{"type":181,"investigatorFullName":55,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Associate professor, Center for Advanced Medical Innovation, Kyushu University","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":194,"type":195},36,"ESTIMATED","INTERVENTIONAL",[198],"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.",[201,202],"Eisenmenger Syndrome","Pulmonary Arterial Hypertension of Congenital Heart Disease",[204,205,206,207],"Eisenmenger syndrome","pulmonary arterial hypertension","Congential heart disease","sotatercept","2026-01-20",{"date":210,"type":211},"2026-01-21","ACTUAL",{"date":213,"type":211},"2025-10-07",{"date":215,"type":195},"2028-04-30",{"name":55,"class":6},10]