[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450056":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":72,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":39,"enrollmentInfo":90,"targetDuration":39,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":54,"whyStopped":39,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Duke University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"participants with inoperable CTEPH","ACTIVE_COMPARATOR","subject with inoperable Chronic thromboembolic Pulmonary Hypertension",[13,14,15],"Drug: Macitentan Tablets","Drug: Riociguat","Device: balloon pulmonary angioplasty",{"label":17,"type":10,"description":18,"interventionNames":19},"post PTE residual CTEPH","Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension",[13,14,15],[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Macitentan Tablets","10 mg oral once daily",[9,17],[27],"OPSUMIT",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Riociguat","1 mg to 2.5mg oral three times daily",[9,17],[33],"Adempas",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DEVICE","balloon pulmonary angioplasty","on hemodynamics and RV function (including advanced assessments of RV-PA coupling",[9,17],null,[41],{"name":42,"affiliation":43,"role":44},"Sudarshan Rajagopal, MD, PhD","Duke Health System","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":39,"email":50},"Claudia Salazar","CONTACT","+1 919 660 2026","claudia.salazar@duke.edu",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-78.89862,35.99403,{"lat":64,"lon":63},[67,71],{"name":68,"role":48,"phone":69,"phoneExt":39,"email":70},"David Ptashnik, MS","9196682642","david.patshnik@duke.edu",{"name":42,"role":44,"phone":39,"phoneExt":39,"email":39},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Dr Sudarshan Rajagopal","Associate Professor of Medicine",[77],{"name":78,"class":79},"Janssen Pharmaceutica N.V., Belgium","INDUSTRY","100450056","phase-3-effects-of-combination-medical-therapy-followed-by-bpa-on-right-ventricular-pa-coupling-and-hemodynamics-in-cteph-100450056",false,"NCT05140525","Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH","Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension","EPIPHANY","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:\n\n1. Age ≥ 18 years' old\n2. Diagnosis of CTEPH\n3. Not a candidate for PTE\n4. Candidate for BPA based on suitable anatomy and disease burden\n5. Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH\u002FPAH-specific medical therapy and treatment with BPA.\n6. Willing and able to give informed consent and adhere to visit\u002Fprotocol schedules (Consent must be given before any study procedures are performed).\n\nExclusion Criteria:\n\n* Subjects presenting with any of the following will not be included in the trials:\n\n  1. Moderate to severe heart disease (LVEF \\\u003C 45% or severe LV Hypertrophy)\n  2. Sarcoidosis\n  3. Active cancer\n  4. Sickle cell anemia\n  5. Liver disease (Childs-Pugh class C)\n  6. Prisoners\n  7. Pregnant, planning pregnancy or lactating\n  8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)\n  9. Contraindication to riociguat or macitentan\n  10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements","ALL","18 Years",{"count":91,"type":92},15,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.",[98],"CTEPH",[100,101],"Inoperable","Post-PTE","2025-10-17",{"date":104,"type":105},"2025-10-21","ACTUAL",{"date":107,"type":105},"2025-01-27",{"date":109,"type":92},"2026-12-31",{"name":74,"class":6},1]