NCT07436689Enrolling by invitationPhase 3
Long-Term Open-Label Extension Study of Oral Levosimendan
A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to provide continued access to treatment with oral levosimendan (TNX-103) and to describe the safety of continued use of TNX-103 in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) who received TNX-103 in a parent study.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 13 Mar 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Tenax Therapeutics, Inc.
- NCT number
- NCT07436689
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 800
- From 13 Mar 2026 to the primary completion date, 31 Mar 2029
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication
Lab values
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²
Other
- Investigator or Sponsor opinion that the participant is unsuitable due to safety, inability to comply, or factors that could compromise study integrity or participant well-being
- Pregnancy or breastfeeding in females
Who the study is looking for
- Completed a TNX-103 parent study
- Investigator confirmation that participant may derive clinical benefit from continued access to TNX-103
- Requirements related to childbearing potential, contraception, and egg/sperm donation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tenax Investigational Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Tenax Investigational Site Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.