Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07436689

Long-Term Open-Label Extension Study of Oral Levosimendan

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Pulmonary Hypertension Associated With HFpEF Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tenax Investigational Site, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNX-103

Drug

Open-label oral levosimendan 1-3mg

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tenax Therapeutics, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.