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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Long-Term Extension Study for Oral Levosimendan (TNX-103)
- ClinicalTrials.gov ID
- NCT07436689
- Acronym / sponsor ID
- TNX-103-08
- Keywords
- PH-HFpEF, levosimendan, HFpEF, Heart Failure, Pulmonary Hypertension Group 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNX-103 | Experimental | Drug: TNX-103Open-label oral levosimendan 1-3mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-103Open-label oral levosimendan 1-3mg | Drug | TNX-103 |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension Associated With HFpEF
Active, not recruitingPhase 3
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RecruitingEarly Phase 1
Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study
Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.