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Enrolling by invitation NCT07436689

Long-Term Open-Label Extension Study of Oral Levosimendan

Phase III Interventional Pulmonary Hypertension Associated With HFpEF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TNX-103.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension Associated With HFpEF. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug TNX-103
    Open-label oral levosimendan 1-3mg

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Tenax Investigational Site — Chicago
  • Tenax Investigational Site — Minneapolis
  • Tenax Investigational Site — Rochester
  • Tenax Investigational Site — St Louis
  • Tenax Investigational Site — Omaha
  • Tenax Investigational Site — Charleston
  • Tenax Investigational Site — Madison

Identifiers

NCT: NCT07436689 · TNX-103-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗