Pulmonary HypertensionPhase 3LEVELNCT05983250
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
A Phase 3 study testing TNX-103 in people with Pulmonary Hypertension, run by Tenax Therapeutics, Inc. at 42 sites in 2 countries.
Trial summary
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- TNX-103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 42 sitesin 2 countries
- Study dates
- 10 Jan 2024to 30 Oct 2028
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
- Qualifying 6-MWD
- A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
- Requirements related to child bearing potential, contraception, and egg/sperm donation
Who cannot join
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the presence of significant valve disease
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- Major surgery within 60 days.
- Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
- History of clinically significant other diseases that may limit or complicate participation in the study.
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States40 sites
Tenax Investigational Site
Atlanta, Georgia, 30322
Tenax Investigational Site
Boston, Massachusetts, 02114
Tenax Investigational Site
Charleston, South Carolina, 29425
Tenax Investigational Site
Chicago, Illinois, 60208
Tenax Investigational Site
Chicago, Illinois, 60637
Tenax Investigational Site
Cincinnati, Ohio, 45267
Tenax Investigational Site
Columbia, South Carolina, 29044
Tenax Investigational Site
Columbus, Ohio, 43214
Tenax Investigational Site
Dallas, Texas, 75204
Tenax Investigational Site
Dallas, Texas, 75390
Tenax Investigational Site
Durham, North Carolina, 27710
Tenax Investigational Site
Galesburg, Illinois, 61401
Tenax Investigational Site
Greensboro, North Carolina, 27401
Tenax Investigational Site
Indianapolis, Indiana, 46202
Tenax Investigational Site
Indianapolis, Indiana, 46260
Tenax Investigational Site
Jacksonville, Florida, 32224
Tenax Investigational Site
La Jolla, California, 92037
Tenax Investigational Site
Los Angeles, California, 90033
Tenax Investigational Site
Los Angeles, California, 90048
Tenax Investigational Site
Louisville, Kentucky, 40202
Tenax Investigational Site
Lubbock, Texas, 79430
Tenax Investigational Site
Madison, Wisconsin, 53792
Tenax Investigational Site
Minneapolis, Minnesota, 55455
Tenax Investigational Site
Murray, Utah, 84107
Tenax Investigational Site
New York, New York, 10021
Tenax Investigational Site
New York, New York, 10029
Tenax Investigational Site
Omaha, Nebraska, 68198
Tenax Investigational Site
Pittsburgh, Pennsylvania, 15212
Tenax Investigational Site
Plano, Texas, 75093
Tenax Investigational Site
Providence, Rhode Island, 02903
Tenax Investigational Site
Richmond, Virginia, 23298
Tenax Investigational Site
Rochester, Minnesota, 55905
Tenax Investigational Site
Rochester, New York, 14621
Tenax Investigational Site
Roslyn, New York, 11576
Tenax Investigational Site
Sacramento, California, 95817
Tenax Investigational Site
San Francisco, California, 94143
Tenax Investigational Site
St Louis, Missouri, 63136
Tenax Investigational Site
Torrance, California, 90502
Tenax Investigational Site
Tucson, Arizona, 85721
Tenax Investigational Site
Winter Haven, Florida, 33881
Canada2 sites
Tenax Investigational Site
London, Ontario, N6A 5A5
Tenax Investigational Site
Winnipeg, Manitoba
About this study
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Read the detailed description
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo
All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
- Conditions
- Pulmonary Hypertension
- Being tested
- TNX-103, Placebo
- Keywords
- HFpEF, Pulmonary hypertension group 2, PH-HFpEF, Heart Failure
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-103Drug
oral levosimendan 1 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| TNX-103 | Active comparator | oral levosimendan Receives: Drug: TNX-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six-minute walk distance
Measured: 12 weeks
Secondary outcomes (4)
KCCQ
Change in KCCQ
Measured: 12 weeks
Clinical Worsening Events
Measured: 12 weeks
Change in NT-proBNP
Decreases in NT-proBNP may indicate an improvement in symptoms
Measured: 12 weeks
Change NYHA functional class
On a scale of I-IV. Lower scores may indicate improvement in symptoms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start10 Jan 2024
- Primary completion30 Jun 2026
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983250
- Sponsor's protocol ID
- TNX-103-06
- Acronym
- LEVEL
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
- ClinicalTrials.gov ID
- NCT05983250
- Acronym / sponsor ID
- LEVEL / TNX-103-06
- Conditions
- Pulmonary Hypertension
- Keywords
- HFpEF, Pulmonary hypertension group 2, PH-HFpEF, Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Northwestern University
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 9 Aug 2023 (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.
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Detailed description
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo
All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| TNX-103 | Active comparator | Drug: TNX-103oral levosimendan |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
Key exclusion criteria (8 listed)
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the presence of significant valve disease
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
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-103oral levosimendan 1 mg | Drug | TNX-103 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in Six-minute walk distance
Time frame: 12 weeks
4 secondary outcomes
KCCQ
Time frame: 12 weeks
Clinical Worsening Events
Time frame: 12 weeks
Change in NT-proBNP
Time frame: 12 weeks
Change NYHA functional class
Time frame: 12 weeks
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 2 countries: 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, run by Tenax Therapeutics, Inc. at 42 sites in 2 countries.
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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Change in Six-minute walk distance (time frame: 12 weeks). 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 24 Jul 2026.