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
—
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.
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.
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