LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF

Last updated: March 7, 2025
Sponsor: Tenax Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Failure

Circulation Disorders

Vascular Diseases

Treatment

TNX-103

Placebo

Clinical Study ID

NCT05983250
TNX-103-06
  • Ages 18-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 qualifyinghemodynamics

  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/spermdonation

Exclusion

Exclusion Criteria:

  1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.

  2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictivecardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrativecardiomyopathy

  3. Structural heart repair or replacement of the aortic valve or mitral valve (surgicalor percutaneous). OR, planned valve intervention. OR, the presence of significantvalve disease

  4. A diagnosis of pre-existing lung disease

  5. History of severe allergic or anaphylactic reaction or hypersensitivity to theexcipients 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 complicateparticipation in the study.

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: TNX-103
Phase: 3
Study Start date:
January 10, 2024
Estimated Completion Date:
May 31, 2028

Study 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.

Connect with a study center

  • St. Boniface Hospital

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • Tenax Investigational Site

    Winnipeg, Manitoba
    Canada

    Active - Recruiting

  • London Health Sciences Center

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Tenax Investigational Site

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Tenax Investigational Site

    Toronto, Ontario M5A 4P5
    Canada

    Active - Recruiting

  • Tenax Investigational Site

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Tucson, Arizona 85721
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Irvine, California 92868
    United States

    Active - Recruiting

  • University of California

    Irvine, California 92868
    United States

    Active - Recruiting

  • University of California, Irvine

    Irvine, California 92868
    United States

    Active - Recruiting

  • Tenax Investigational Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Sacramento, California 95817
    United States

    Active - Recruiting

  • UC Davis Health Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California- Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Tenax Investigational Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of California

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of California, San Francisco- Heart and Vascular Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Tenax Investigational Site

    Washington DC, District of Columbia 20010
    United States

    Active - Recruiting

  • Mato Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Winter Haven, Florida 33881
    United States

    Active - Recruiting

  • Winter Haven Hospital

    Winter Haven, Florida 33881
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Galesburg, Illinois 61401
    United States

    Active - Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Ascension Medical Group

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Norton Pulmonary Specialists

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • M Health Fairview; U. of Minnesota Medical Center, East Bank

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • U. of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • St. Louis Heart and Vascular

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Tenax Investigational Site

    St. Louis, Missouri 63136
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Tenax Investigational Site

    New York, New York 10021
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Rochester, New York 14621
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Moses H. Cone Memorial Hospital Operating Corp; Cone Health

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prism Health Cardiology

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Prisma Health Cardiology

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Tenax Investigational Site

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Texas Tech Physicians of El Paso

    El Paso, Texas 79905
    United States

    Site Not Available

  • Tenax Investigational Site

    Lubbock, Texas 79430
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Revival Research Institute

    Sherman, Texas 75092
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin Hospital

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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