Long-Term Open-Label Extension Study of Oral Levosimendan
Enrolling by invitation · Phase 3
Conditions studied: Pulmonary Hypertension Associated With HFpEF
In brief
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.
Key facts
- Study ID
- NCT07436689
- Run by
- Tenax Therapeutics, Inc.
- People needed
- 800
- Starts
- 2026-03-13
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Severe hepatic impairment or cirrhosis (Child-Pugh C) or active untreated hepatitis B or C with evidence of recent infection or viral replication
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
- Pregnancy or breastfeeding in females
Where it is running
- Tenax Investigational Site — Chicago, Illinois, United States
- Tenax Investigational Site — Minneapolis, Minnesota, United States
- Tenax Investigational Site — Rochester, Minnesota, United States
- Tenax Investigational Site — St Louis, Missouri, United States
- Tenax Investigational Site — Omaha, Nebraska, United States
- Tenax Investigational Site — Charleston, South Carolina, United States
- Tenax Investigational Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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