[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-hypertension-associated-with-hfpef\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-hypertension-associated-with-hfpef":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644352","early-phase-1-percutaneous-pulmonary-artery-denervation-padn-for-the-treatment-of-pulmonary-hypertension-after-transcatheter-mitral-valve-edge-to-edge-repair-m-teer-a-prospective-cohort-study-100644352",false,"NCT07662655","Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study","Inclusion Criteria:\n\n1. Age ≥18 years and ≤80 years;\n2. Diagnosed with pulmonary hypertension (defined as mPAP \\>20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;\n3. No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);\n4. Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;\n5. Willing to comply with the treatment and follow-up schedule required by the protocol\n\nExclusion Criteria:\n\n1. Cardiac index (CI) \\\u003C 1.5 L\u002Fmin\u002Fm²;\n2. Severe renal insufficiency (creatinine clearance rate (CrCL) \\\u003C 30 mL\u002Fmin);\n3. Left ventricular ejection fraction (EF) \\\u003C30% on echocardiography;\n4. Severe hematological disease or severe bleeding tendency (platelet count \\\u003C10×10⁹\u002FL; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);\n5. Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;\n6. Acute systemic infectious disease;\n7. Poor general condition due to various systemic diseases;\n8. Pulmonary veno-occlusive disease;\n9. Cachexia;\n10. Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;\n11. Anticipated to undergo other surgical or interventional procedures within 6 months;\n12. Life expectancy \\\u003C12 months;\n13. Allergy to the drugs or metal materials used in the study;\n14. Women who are breastfeeding, pregnant, or planning to become pregnant within one year;\n15. Participation in another drug or medical device clinical trial within 3 months prior to screening;\n16. Any condition deemed unsuitable for participation in this clinical trial by the investigator. \\|","ALL","18 Years","80 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making",[26,27],"Pulmonary Hypertension","Pulmonary Hypertension Associated With HFpEF","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2026-06-06",{"date":36,"type":20},"2028-08-31",{"name":38,"class":39},"Xiamen Cardiovascular Hospital, Xiamen University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100615114","phase-3-level-2-levosimendan-to-improve-exercise-limitation-in-patients-with-ph-hfpef-2-100615114","NCT07288398","LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction","LEVEL-2","Inclusion Criteria:\n\n1. Men or women, ≥18 to 85 years of age\n2. NYHA Class II or III or ambulatory NYHA Class IV symptoms\n3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)\n4. A qualifying baseline RHC\n5. A qualifying echocardiogram\n6. A qualifying 6-MWD\n7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period\n8. Requirements related to child bearing potential, contraception, and egg\u002Fsperm donation)\n\nExclusion Criteria:\n\n1. A diagnosis of PH WHO Groups 1, 3, 4, or 5\n2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy\n3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease\n4. A diagnosis of pre-existing lung disease\n5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product\n6. Major surgery within 60 days\n7. Prior heart, lung, or heart-lung transplants or life expectancy of \\\u003C12 months\n8. History of clinically significant other diseases that may limit or complicate participation in the study","85 Years",{"count":51,"type":20},540,[53],"PHASE3","The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.",[27],[57,58,59,60,61],"PH-HFpEF","levosimendan","HFpEF","Heart Failure","Pulmonary Hypertension Group 2","2026-03-12",{"date":64,"type":32},"2026-03-16",{"date":66,"type":32},"2026-03-03",{"date":68,"type":20},"2029-06-30",{"name":70,"class":71},"Tenax Therapeutics, Inc.","INDUSTRY",92]