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Enrolling By Invitation
NCT07436689
Long-Term Open-Label Extension Study of Oral Levosimendan
Conditions: Pulmonary Hypertension Associated With HFpEF
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 800
Sponsor: Tenax Therapeutics, Inc.
Location: Tenax Investigational Site Chicago Illinois
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 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
Source: ClinicalTrials.gov (NCT07436689). StuddyBuddy aggregates publicly available trial information.