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Clinical Trials in the USA / NCT07436689
Enrolling by invitation Phase 3

Long-Term Open-Label Extension Study of Oral Levosimendan

NCT07436689 · tracked via the Priya Life Science USA tracker
Sponsor
Tenax Therapeutics, Inc
Phase
Phase 3
Started
2026-03-13
Last updated
2026-10-20

Condition(s) studied

Pulmonary Hypertension Associated With HFpEF

Investigational drug(s) / intervention(s)

TNX-103 →

TNX-103: Open-label oral levosimendan 1-3mg

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs — From enrollment through study completion (up to 3 years)
    The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs will be tabulated by system organ class and preferred term.

Trial sites (10)

FacilityCityRegionStatus
Tenax Investigational Site Chicago Illinois
Tenax Investigational Site Boston Massachusetts
Tenax Investigational Site Minneapolis Minnesota
Tenax Investigational Site Rochester Minnesota
Tenax Investigational Site St Louis Missouri
Tenax Investigational Site Omaha Nebraska
Tenax Investigational Site New York New York
Tenax Investigational Site Durham North Carolina
Tenax Investigational Site Charleston South Carolina
Tenax Investigational Site Madison Wisconsin

More Tenax Therapeutics, Inc. trials in the USA

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF Active, not recruiting
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 Active, not recruiting

Other trials for the same condition

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07436689 on ClinicalTrials.gov ↗ ← All trials in the USA