Pulmonary Hypertension Associated With HFpEFPhase 3NCT07436689
Long-Term Open-Label Extension Study of Oral Levosimendan
A Phase 3 study testing TNX-103 in people with Pulmonary Hypertension Associated With HFpEF, run by Tenax Therapeutics, Inc. at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Associated With HFpEF
- What is being tested?
- TNX-103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Mar 2026to Mar 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Tenax Investigational Site
Boston, Massachusetts, 02114
Tenax Investigational Site
Charleston, South Carolina, 29425
Tenax Investigational Site
Chicago, Illinois, 60611
Tenax Investigational Site
Durham, North Carolina, 27710
Tenax Investigational Site
Madison, Wisconsin, 53792
Tenax Investigational Site
Minneapolis, Minnesota, 55455
Tenax Investigational Site
New York, New York, 10021
Tenax Investigational Site
Omaha, Nebraska, 68198
Tenax Investigational Site
Rochester, Minnesota, 55905
Tenax Investigational Site
St Louis, Missouri, 63136
About this study
Official title: A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
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.
- Being tested
- TNX-103
- Keywords
- PH-HFpEF, levosimendan, HFpEF, Heart Failure, Pulmonary Hypertension Group 2
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-103Drug
Open-label oral levosimendan 1-3mg
| Study group | Role | What they receive |
|---|---|---|
| TNX-103 | Experimental | Open-label oral levosimendan 1-3mg Receives: Drug: TNX-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through study completion (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start13 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Associated With HFpEFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436689
- Sponsor's protocol ID
- TNX-103-08
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No