NCT05983250 LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
| NCT ID | NCT05983250 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tenax Therapeutics, Inc. |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2026-10 |
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 230 participants in total. It began in 2024-01-10 with a primary completion date of 2026-10.
⚠ 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
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).
Eligibility Criteria
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 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 NCT05983250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Pulmonary Hypertension. 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 NCT05983250 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 230 participants.
Is NCT05983250 currently recruiting?
Yes, NCT05983250 is actively recruiting participants. Contact the research team at k.crawford@tenaxthera.com for enrollment information.
Where is the NCT05983250 trial being conducted?
This trial is being conducted at Tucson, United States, La Jolla, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05983250 clinical trial?
NCT05983250 is sponsored by Tenax Therapeutics, Inc.. The trial plans to enroll 230 participants.