[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tenax Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100615114","phase-3-level-2-levosimendan-to-improve-exercise-limitation-in-patients-with-ph-hfpef-2-100615114",false,"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","ALL","18 Years","85 Years",{"count":21,"type":22},540,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Pulmonary Hypertension Associated With HFpEF",[30,31,32,33,34],"PH-HFpEF","levosimendan","HFpEF","Heart Failure","Pulmonary Hypertension Group 2","RECRUITING","2026-03-12",{"date":38,"type":39},"2026-03-16","ACTUAL",{"date":41,"type":39},"2026-03-03",{"date":43,"type":22},"2029-06-30",{"name":45,"class":46},"Tenax Therapeutics, Inc.","INDUSTRY",92,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100514803","phase-3-levosimendan-to-improve-exercise-limitation-in-patients-with-ph-hfpef-100514803","NCT05983250","LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)","LEVEL","Inclusion Criteria:\n\n1. Men or women, greater than or equal to18 to 85 years of age.\n2. NYHA Class II or III or NYHA class IV symptoms.\n3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics\n4. Qualifying Baseline RHC.\n5. Qualifying echocardiogram\n6. 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.",{"count":57,"type":22},230,[25],"This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).",[61],"Pulmonary Hypertension",[32,63,30,33],"Pulmonary hypertension group 2","2026-02-13",{"date":66,"type":39},"2026-02-18",{"date":68,"type":39},"2024-01-10",{"date":70,"type":22},"2028-10",{"name":45,"class":46},44,""]