Continued Oral Levosimendan Treatment for Pulmonary Hypertension With Preserved-Ejection Heart Failure
Continues oral levosimendan and tracks its safety in people who took it earlier.
Plain-language title generated from the registry record
Registry title: Long-Term Open-Label Extension Study of Oral Levosimendan
Key facts
- Where
- Boston, Charleston, Chicago, Durham, Madison, Minneapolis, New York, Omaha, Rochester, and St Louis, United StatesSee the 10 sites
- Phase
- Phase 3
Where in United States
- BostonBoston, United StatesNo longer taking part
- CharlestonCharleston, United StatesNo longer taking part
- ChicagoChicago, United StatesNo longer taking part
- DurhamDurham, United StatesNo longer taking part
- MadisonMadison, United StatesNo longer taking part
- MinneapolisMinneapolis, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- OmahaOmaha, United StatesNo longer taking part
- RochesterRochester, United StatesNo longer taking part
- St LouisSt Louis, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tenax Therapeutics, Inc.
- Trial code
- NCT07436689
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
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.
Inclusion: 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.
Exclusion: 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; 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.