LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
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).
| Condition(s) | Pulmonary Hypertension |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Inclusion Criteria: 1. Men or women, greater than or equal to18 to 85 years of age. 2. NYHA Class II or III or NYHA class IV symptoms. 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics 4. Qualifying Baseline RHC. 5. Qualifying echocardiogram 6. Qualifying 6-MWD 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period. 8. Requirements related to child bearing potential, contraception, and egg/sperm donation Exclusion Criteria: 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5. 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy 3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical o |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Tenax Therapeutics, Inc. |
| Locations | Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States (+38 more sites) |
| Start date | 2024-01-10 |
| NCT ID | NCT05983250 |
| Official listing | https://clinicaltrials.gov/study/NCT05983250 |