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New pill could help heart failure patients breathe easier and walk farther

NCT ID NCT05983250

Disease control Sponsor: Tenax Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests an oral medication called levosimendan in people who have both pulmonary hypertension (high blood pressure in the lungs) and a type of heart failure where the heart pumps normally but is stiff. The goal is to see if the drug helps them walk farther in 6 minutes compared to a placebo. About 230 adults aged 18 to 85 with moderate to severe symptoms will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men or women, greater than or equal to18 to 85 years of age. 2. NYHA Class II or III or NYHA class IV symptoms. 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics 4. Qualifying Baseline RHC. 5. Qualifying echocardiogram 6. Qualifying 6-MWD 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period. 8. Requirements related to child bearing potential, contraception, and egg/sperm donation Exclusion Criteria: 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5. 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy 3. 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 4. A diagnosis of pre-existing lung disease 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product. 6. Major surgery within 60 days. 7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months 8. History of clinically significant other diseases that may limit or complicate participation in the study.

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Conditions

The condition(s) this trial relates to.

heart failure pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension

Contacts and locations

Locations

  • Tenax Investigational Site

    Tucson, Arizona, 85721, United States

  • Tenax Investigational Site

    La Jolla, California, 92037, United States

  • Tenax Investigational Site

    Los Angeles, California, 90033, United States

  • Tenax Investigational Site

    Los Angeles, California, 90048, United States

  • Tenax Investigational Site

    Sacramento, California, 95817, United States

  • Tenax Investigational Site

    San Francisco, California, 94143, United States

  • Tenax Investigational Site

    Torrance, California, 90502, United States

  • Tenax Investigational Site

    Jacksonville, Florida, 32224, United States

  • Tenax Investigational Site

    Winter Haven, Florida, 33881, United States

  • Tenax Investigational Site

    Atlanta, Georgia, 30322, United States

  • Tenax Investigational Site

    Chicago, Illinois, 60208, United States

  • Tenax Investigational Site

    Chicago, Illinois, 60637, United States

  • Tenax Investigational Site

    Galesburg, Illinois, 61401, United States

  • Tenax Investigational Site

    Indianapolis, Indiana, 46202, United States

  • Tenax Investigational Site

    Indianapolis, Indiana, 46260, United States

  • Tenax Investigational Site

    Louisville, Kentucky, 40202, United States

  • Tenax Investigational Site

    Boston, Massachusetts, 02114, 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

    New York, New York, 10021, United States

  • Tenax Investigational Site

    New York, New York, 10029, United States

  • Tenax Investigational Site

    Rochester, New York, 14621, United States

  • Tenax Investigational Site

    Roslyn, New York, 11576, United States

  • Tenax Investigational Site

    Durham, North Carolina, 27710, United States

  • Tenax Investigational Site

    Greensboro, North Carolina, 27401, United States

  • Tenax Investigational Site

    Cincinnati, Ohio, 45267, United States

  • Tenax Investigational Site

    Columbus, Ohio, 43214, United States

  • Tenax Investigational Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Tenax Investigational Site

    Providence, Rhode Island, 02903, United States

  • Tenax Investigational Site

    Charleston, South Carolina, 29425, United States

  • Tenax Investigational Site

    Columbia, South Carolina, 29044, United States

  • Tenax Investigational Site

    Dallas, Texas, 75204, United States

  • Tenax Investigational Site

    Dallas, Texas, 75390, United States

  • Tenax Investigational Site

    Lubbock, Texas, 79430, United States

  • Tenax Investigational Site

    Plano, Texas, 75093, United States

  • Tenax Investigational Site

    Murray, Utah, 84107, United States

  • Tenax Investigational Site

    Richmond, Virginia, 23298, United States

  • Tenax Investigational Site

    Madison, Wisconsin, 53792, United States

  • Tenax Investigational Site

    Winnipeg, Manitoba, Canada

  • Tenax Investigational Site

    London, Ontario, N6A 5A5, Canada

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