Long-Term Open-Label Extension Study of Oral Levosimendan
A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
1 other identifier
interventional
800
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
July 20, 2026
July 1, 2026
3 years
February 20, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence (i.e., the percentage of patients who experience at least 1 occurrence) of select AE/SAEs
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.
From enrollment through study completion (up to 3 years)
Study Arms (1)
TNX-103
EXPERIMENTALOpen-label oral levosimendan 1-3mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Tenax Investigational Site
Chicago, Illinois, 60611, United States
Tenax Investigational Site
Minneapolis, Minnesota, 55455, United States
Tenax Investigational Site
Rochester, Minnesota, 55905, United States
Tenax Investigational Site
St Louis, Missouri, 63136, United States
Tenax Investigational Site
Omaha, Nebraska, 68198, United States
Tenax Investigational Site
Charleston, South Carolina, 29425, United States
Tenax Investigational Site
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2026
First Posted
February 27, 2026
Study Start
March 13, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share