NCT07288398 LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
| NCT ID | NCT07288398 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tenax Therapeutics, Inc. |
| Condition | Pulmonary Hypertension Associated With HFpEF |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 540 participants in total. It began in 2026-03-03 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Men or women, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A 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 or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease 4. A diagnosis of pre-existing lung disease 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product 6. Major surgery within 60 days 7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months 8. History of clinically significant other diseases that may limit or complicate participation in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07288398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pulmonary Hypertension Associated With HFpEF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07288398 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 540 participants.
Is NCT07288398 currently recruiting?
Yes, NCT07288398 is actively recruiting participants. Contact the research team at a.ashokkumar@tenaxthera.com for enrollment information.
Where is the NCT07288398 trial being conducted?
This trial is being conducted at Alexander City, United States, Tamarac, United States, Mount Prospect, United States, Peoria, United States and 11 additional locations.
Who is sponsoring the NCT07288398 clinical trial?
NCT07288398 is sponsored by Tenax Therapeutics, Inc.. The trial plans to enroll 540 participants.