By InvitationPhase 3

Long-Term Open-Label Extension Study of Oral Levosimendan

United States800 participantsStarted 2026-03-13

Plain-language summary

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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs

Timeframe: From enrollment through study completion (up to 3 years)

Trial details

NCT IDNCT07436689

SponsorTenax Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03

View on ClinicalTrials.gov More Pulmonary Hypertension Associated With HFpEF trials