[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cteph\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cteph":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,73,97,122,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100642809","phase-3-discontinuation-versus-continuation-of-riociguat-monotherapy-in-chronic-thromboembolic-pulmonary-hypertension-successfully-treated-with-balloon-pulmonary-angioplasty-100642809",false,"NCT07644377","Discontinuation Versus Continuation of Riociguat Monotherapy in Chronic Thromboembolic Pulmonary Hypertension Successfully Treated With Balloon Pulmonary Angioplasty","DIRECTION","Inclusion Criteria:\n\n* 1\\. Signed informed consent and willingness to accept either discontinuation or continuation of riociguat monotherapy\n* 2\\. Age ≥18 years\n* 3\\. Diagnosis of inoperable CTEPH or persistent PH after PEA, with achievement of therapeutic goals following BPA, defined as:\n\n  1. WHO FC I or II\n  2. Pulmonary vascular resistance (PVR) \\\u003C 3 Wood units\n  3. Mean pulmonary artery pressure (mPAP) \\\u003C 30 mmHg\n* 4\\. Treatment with riociguat monotherapy for ≥6 months, with stable dose for ≥3 months prior to enrollment\n* 5\\. Last BPA session performed ≥6 months prior to enrollment\n* 6\\. 6-minute walk distance (6MWD) ≥ 150 meters\n* 7\\. For women of childbearing potential: highly effective contraception\n\nExclusion Criteria:\n\n* 1\\. Background treatment with any PH-targeted therapy other than riociguat, (e.g., any endothelin receptor antagonist (ERA), phosphodiesterase-5 inhibitor (PDE-5i), parenteral prostanoids, prostacyclin receptor agonist)\n* 2\\. Post-capillary pulmonary hypertension, defined as pulmonary artery wedge pressure (PAWP) \\> 15 mmHg\n* 3\\. Significant obstructive or restrictive lung disease, defined as:\n* FEV₁ \\\u003C 60% predicted, with FEV₁\u002FFVC \\\u003C 65%\n* and\u002For total lung capacity (TLC) \\\u003C 60% predicted\n* or known significant chronic lung disease on imaging (e.g., interstitial lung disease, emphysema)\n* 4\\. Severe hepatic impairment, defined as:\n* Child-Pugh class B or C\n* and\u002For liver aminotransferase levels \\> 3× upper limit of normal (ULN)\n* 5\\. Severe renal impairment (estimated creatinine clearance ≤ 30 mL\u002Fmin\u002F1.73 m²).\n* 6\\. Left heart failure with left ventricular ejection fraction (LVEF) \\\u003C 40%\n* 7\\. Ongoing or planned treatment with organic nitrates.\n* 8\\. Concomitant treatment with strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., rifabutin, rifampicin, carbamazepine, phenobarbital, phenytoin, St. John's wort)\n* 9\\. Concomitant treatment with strong multi pathway P-glycoprotein (P-gp)\u002F breast cancer resistance protein (BCRP) inhibitors (e.g., lopinavir\u002Fritonavir).\n* 10\\. Treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) or a moderate dual CYP3A4\u002FCYP2C9 inhibitor (e.g., fluconazole, amiodarone) or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors.\n* 11\\. History of life-threatening hemoptysis (\\>100 mL within 24 hours) or prior bronchial artery embolization for hemoptysis\n* 12\\. Pregnancy, breastfeeding, or intention to become pregnant during the study period\n* 13\\. Severe comorbidities or underlying conditions with an anticipated life expectancy \\\u003C 12 months, including active malignancy with localized or metastatic disease\n* 14\\. Lack of coverage by national health or social security systems\n* 15\\. Alcohol abuse, as determined by the investigator\n* 16\\. Any condition or factor likely to interfere with protocol compliance, in the opinion of the investigator\n* 17\\. Patient under guardianship or curatorship\n* 18\\. Participation in another interventional trial or being in the exclusion period following a previous research involving the human person","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but severe complication of acute pulmonary embolism, characterized by persistent obstruction of the pulmonary arteries by organized thrombi and secondary microvasculopathy. International guidelines recommend a multimodal approach combining pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA), and medical treatment with riociguat, to address the full spectrum of CTEPH lesions. BPA and riociguat are recommended for symptomatic patients with inoperable CTEPH or persistent pulmonary hypertension after PEA. Riociguat is administered before BPA to reduce periprocedural complications by improving pulmonary hemodynamics. While this pre-BPA strategy is well established, post-BPA management is poorly studied, especially in patients achieving therapeutic goals, defined as WHO functional class I or II and near-normal resting pulmonary hemodynamics (70 to 80% of cases). In such cases, riociguat monotherapy is often continued long-term, despite its cost, burden, and potential side effects, which may negatively impact patients' quality of life. Retrospective single-center studies suggest that discontinuation of medical treatment does not lead to significant clinical deterioration. Therefore, we propose conducting a multicenter trial using a PROBE (prospective, randomized, open-label, blinded endpoint) design and a Bayesian approach to test if stopping riociguat monotherapy after successful BPA is associated with an acceptably low risk of clinical worsening over a follow-up period of at least one year compared to continuation. The trial will also assess the cost-effectiveness of riociguat discontinuation.",[26],"CTEPH",[28],"riociguat discontinuation","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":20},"2026-10-01",{"date":37,"type":20},"2031-01-31",{"name":39,"class":40},"Assistance Publique - Hôpitaux de Paris","OTHER",22,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100633093","arterial-wave-energy-flux-and-multidimensional-recovery-in-patients-with-chronic-thromboembolic-pulmonary-hypertension-undergoing-balloon-pulmonary-angioplasty-100633093","NCT07522203","Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty","WE FIX BPA","Inclusion Criteria:\n\n* Age 18-85 years.\n\nConfirmed diagnosis of CTEPH by a multidisciplinary CTEPH team and deemed eligible for BPA.\n\nHemodynamics compatible with pre-capillary PH according to current guidelines, as assessed by RHC (Right Heart Catheterization).\n\nTechnically inoperable CTEPH or persistent\u002Frecurrent PH following PEA (Pulmonary Endarterectomy).\n\nWritten informed consent.\n\nExclusion Criteria:\n\n* Predominant diagnosis of PH other than CTEPH or concomitant severe parenchymal lung disease.\n\nActive infection, uncontrolled systemic disease, active malignancy, or life expectancy \\\u003C 12 months.\n\nPregnant or lactating patients.\n\nAdvanced renal failure (e.g., eGFR \\\u003C 30 \\\\text{ mL\u002Fmin\u002F1.73 m\\^2}) or contraindications to contrast media (per institutional routine).\n\nInadequate image quality precluding reliable echocardiographic analysis.\n\nPressure tracings with significant artifacts hindering analysis or uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response).\n\nDecompensated or hemodynamically unstable patients.\n\nAny other condition deemed clinically unsuitable by the investigator.","85 Years",{"count":51,"type":20},70,"12 Months","OBSERVATIONAL","The goal of this observational study is to learn if advanced heart pressure wave analysis (called WIA and REPA) can help track and predict clinical improvement in adults (aged 18-85) with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are undergoing Balloon Pulmonary Angioplasty (BPA).\n\nThe main questions it aims to answer are:\n\nDo changes in these advanced heart pressure wave patterns relate to improvements in a patient's walking distance, heart function, and overall quality of life after BPA treatment?\n\nAre these new measurements more effective than standard heart pressure tests at showing how much a patient has truly improved?\n\nParticipants will:\n\nUndergo standard Balloon Pulmonary Angioplasty (BPA) sessions as part of their regular medical care for CTEPH.\n\nHave their heart pressure waves recorded through a catheter during the routine BPA procedure (this does not require any extra surgical steps).\n\nComplete walking tests (6-minute walk test), blood tests, and heart ultrasounds (echocardiography) before starting the treatment and after it is completed.\n\nFill out short surveys regarding their daily physical activity and quality of life.",[26,56],"Pulmonary Hypertension (PH)",[58,59,60],"Arterial Wave Energy","Hemodynamics","Balloon Pulmonary Angioplasty","RECRUITING","2026-04-03",{"date":64,"type":33},"2026-04-13",{"date":66,"type":33},"2026-03-10",{"date":68,"type":20},"2028-05-01",{"name":70,"class":71},"Istanbul Mehmet Akif Ersoy Educational and Training Hospital","OTHER_GOV",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100615947","impact-of-bpa-in-cteph-on-cardiac-and-pulmonary-physiology-assessed-by-cmr-derived-4d-flow-haemodynamics-100615947","NCT07299227","Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics","Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics","Inclusion Criteria:\n\n* Patient referred to BPA\n* clinical indication for CMR\n* capability to give informed consent\n\nExclusion Criteria:\n\n* general: non-compliance, \\\u003C18 years of age, pregnancy\n* contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR \\\u003C30ml\u002Fmin), allergies (medications)","99 Years",{"count":82,"type":20},60,"Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT\u002FCMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.",[26],[26,86,87],"CMR","4D flow","2025-12-09",{"date":90,"type":33},"2025-12-23",{"date":92,"type":33},"2025-09-01",{"date":94,"type":20},"2028-12-31",{"name":96,"class":40},"Kerckhoff Klinik",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":72},"100450056","phase-3-effects-of-combination-medical-therapy-followed-by-bpa-on-right-ventricular-pa-coupling-and-hemodynamics-in-cteph-100450056","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",{"count":106,"type":20},15,[23],"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.",[26],[111,112],"Inoperable","Post-PTE","2025-10-17",{"date":115,"type":33},"2025-10-21",{"date":117,"type":33},"2025-01-27",{"date":119,"type":20},"2026-12-31",{"name":121,"class":40},"Dr Sudarshan Rajagopal",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"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":131,"type":20},84,[133],"NA","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.",[136,26],"PAH","2025-05-14",{"date":139,"type":33},"2025-05-15",{"date":141,"type":20},"2025-05-20",{"date":143,"type":20},"2027-10-31",{"name":145,"class":40},"Beijing Chao Yang Hospital",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":155,"studyType":53,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":72},"100524170","biological-sex-and-cteph-related-rv-dysfunction-and-recovery-biosphere-100524170","NCT06105242","Biological Sex and CTEPH-related RV Dysfunction and Recovery (BIOSPHeRe)","Biological Sex and Sex Hormones Moderate Right Ventricular (RV) Dysfunction and Recovery in Chronic Thromboembolic Pulmonary Hypertension","Inclusion criteria\n\n* Adult (≥18 years old) patients diagnosed with CTEPH per current guideline standard42\n* Subject must have a baseline TTE (within 3 months of diagnosis) with adequate images for RVGLS analysis\n* Subject must have a right heart catheterization (RHC) at the time of diagnosis\n* To be included in the Aim 2 analysis, patients must undergo PTE surgery and have a TTE performed 3-9 months after surgery with adequate images for RVGLS strain analysis\n\nExclusion criteria\n\n* Unclear or mixed PH diagnosis as designated by an expert clinician at Intermountain PH center\n* Any subjects \\\u003C18 years of age\n* Patients diagnosed during pregnancy\n* Patients without a TTE and RHC at time of diagnosis",{"count":154,"type":20},10,"6 Months","1. To identify biological sex differences in baseline RV function in CTEPH\n2. To identify biological sex differences in recovery of RV function after PTE surgery in CTEPH\n3. To determine if sex hormone levels relate to RV function at CTEPH diagnosis and during recovery after PTE.",[26],"2023-10-23",{"date":160,"type":33},"2023-10-27",{"date":162,"type":33},"2022-05-30",{"date":119,"type":20},{"name":165,"class":40},"Intermountain Health Care, Inc."]