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New pill aims to help heart failure patients breathe easier and walk farther

NCT ID NCT07288398

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This study tests an oral drug called levosimendan against a placebo in 540 adults with pulmonary hypertension and a type of heart failure (HFpEF). The main goal is to see if the drug helps people walk farther in six minutes. Participants must be 18-85 years old with specific heart and lung measurements. The drug is not a cure but aims to control the disease and ease symptoms.

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 540 people

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

Started

Mar 2026

Expected to finish

Jun 2029

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, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A 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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Get notified about this study

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Pulmonary hypertension associated with hfpef

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    140 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tenax Investigational Site

    RECRUITING

    Alexander City, Alabama, 35010, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Tucson, Arizona, 85724, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Sacramento, California, 95816, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    San Francisco, California, 94143, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Stanford, California, 94305-5208, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Torrance, California, 90502, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Athens, Georgia, 30606, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611-4494, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Mount Prospect, Illinois, 60056, United States

  • Tenax Investigational Site

    RECRUITING

    Peoria, Illinois, 61636, United States

  • Tenax Investigational Site

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Tenax Investigational Site

    RECRUITING

    New Orleans, Louisiana, 70115-6969, United States

  • Tenax Investigational Site

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114-2621, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Tenax Investigational Site

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64111, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    St Louis, Missouri, 63136, United States

  • Tenax Investigational Site

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Tenax Investigational Site

    RECRUITING

    Reno, Nevada, 89502, United States

  • Tenax Investigational Site

    RECRUITING

    New York, New York, 10021, United States

  • Tenax Investigational Site

    RECRUITING

    New York, New York, 10032, United States

  • Tenax Investigational Site

    RECRUITING

    Rochester, New York, 14617, United States

  • Tenax Investigational Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Tenax Investigational Site

    RECRUITING

    Winston-Salem, North Carolina, 27101, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195-0001, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Allentown, Pennsylvania, 18105, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Wynnewood, Pennsylvania, 19096-3450, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Tenax Investigational Site

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Tenax Investigational Site

    RECRUITING

    Austin, Texas, 78705, United States

  • Tenax Investigational Site

    RECRUITING

    Dallas, Texas, 75390, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    El Paso, Texas, 79905-2707, United States

  • Tenax Investigational Site

    WITHDRAWN

    Houston, Texas, 77002, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030-2342, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Norfolk, Virginia, 23507-1904, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Seattle, Washington, 98122, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53706, United States

  • Tenax Investigational Site

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    San Juan Bautista, Buenos Aires, 1888, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Buenos Aires, Buenos Aires F.D., 1280, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Buenos Aires, C1180AAX, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Buenos Aires, C1428ART, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Corrientes, W3400AMZ, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Córdoba, 5000, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Córdoba, X5016KET, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    San Luis, D5702JRS, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Santa Fe, S2002KDS, Argentina

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Tenax Investigational Site

    RECRUITING

    Braunau am Inn, 5280, Austria

  • Tenax Investigational Site

    RECRUITING

    Graz, 8036, Austria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Klagenfurt, 9020, Austria

  • Tenax Investigational Site

    RECRUITING

    Sankt Pölten, 3100, Austria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Vienna, 1100, Austria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Salvador, Estado de Bahia, 40170-130, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Goiânia, Goiás, 74605, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Belo Horizonte, Minas Gerais, 30220, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Curitiba, Paraná, 80215-901, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Ribeirão Preto, São Paulo, 14026-020, Brazil

  • Tenax Investigational Site

    RECRUITING

    Burgas, 8000, Bulgaria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pleven, 5800, Bulgaria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Sofia, 1309, Bulgaria

  • Tenax Investigational Site

    RECRUITING

    Sofia, 1407, Bulgaria

  • Tenax Investigational Site

    RECRUITING

    Sofia, 1431, Bulgaria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Sofia, 1750, Bulgaria

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Ostrava, 72880, Czechia

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Prague, 10034, Czechia

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Prague, 15006, Czechia

  • Tenax Investigational Site

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • Tenax Investigational Site

    RECRUITING

    Nantes, 44007, France

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Nice, 06001, France

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pau, 64000, France

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Poitiers, 86000, France

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Bad Bevensen, 29549, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Bad Nauheim, 61231, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Berlin, 12683, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Hamburg, 20251, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Jena, 07747, Germany

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • Tenax Investigational Site

    RECRUITING

    Budapest, 1122, Hungary

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Budapest, 1134, Hungary

  • Tenax Investigational Site

    RECRUITING

    Debrecen, 4032, Hungary

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Szeged, 6275, Hungary

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Acquaviva delle Fonti, 70021, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Messina, 98125, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Milan, 20138, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Milan, 20149, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pisa, 56126, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Grodzisk Mazowiecki, 05-825, Poland

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Poznan, 61848, Poland

  • Tenax Investigational Site

    RECRUITING

    Wroclaw, 50556, Poland

  • Tenax Investigational Site

    RECRUITING

    Wroclaw, 50891, Poland

  • Tenax Investigational Site

    RECRUITING

    Cheongju-si, 28644, South Korea

  • Tenax Investigational Site

    RECRUITING

    Gwangju, 61469, South Korea

  • Tenax Investigational Site

    RECRUITING

    Incheon, 21565, South Korea

  • Tenax Investigational Site

    RECRUITING

    Seoul, 03080, South Korea

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Seoul, 08308, South Korea

  • Tenax Investigational Site

    RECRUITING

    Wŏnju, 26426, South Korea

  • Tenax Investigational Site

    RECRUITING

    Barcelona, 08003, Spain

  • Tenax Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • Tenax Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • Tenax Investigational Site

    RECRUITING

    Lugo, 27003, Spain

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Tenax Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • Tenax Investigational Site

    RECRUITING

    Madrid, 28055, Spain

  • Tenax Investigational Site

    RECRUITING

    Marbella, 29603, Spain

  • Tenax Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Pamplona, 31008, Spain

  • Tenax Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • Tenax Investigational Site

    RECRUITING

    Seville, 41009, Spain

  • Tenax Investigational Site

    RECRUITING

    Toledo, 45007, Spain

  • Tenax Investigational Site

    RECRUITING

    Valencia, 46010, Spain

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Valencia, 46020, Spain

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Kaohsiung City, 813414, Taiwan

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Tainan, 71004, Taiwan

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Taipei, 10449, Taiwan

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Taipei, 110, Taiwan

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Taoyuan, 33305, Taiwan

  • Tenax Investigational Site

    RECRUITING

    Cambridge, CB233RE, United Kingdom

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Glasgow, G81 4HS, United Kingdom

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    London, SW3 6NP, United Kingdom

  • Tenax Investigational Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Tenax Investigational Site

    NOT_YET_RECRUITING

    Swindon, SN36BB, United Kingdom

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