RECRUITING

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

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Conditions

Pulmonary HypertensionHFpEFPulmonary hypertension group 2PH-HFpEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2024-01-10
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05983250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men or women, greater than or equal to18 to 85 years of age.
  2. 2. NYHA Class II or III or NYHA class IV symptoms.
  3. 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
  4. 4. Qualifying Baseline RHC.
  5. 5. Qualifying echocardiogram
  6. 6. Qualifying 6-MWD
  7. 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
  8. 8. Requirements related to child bearing potential, contraception, and egg/sperm donation
  1. 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
  2. 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  3. 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. 4. A diagnosis of pre-existing lung disease
  5. 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
  6. 6. Major surgery within 60 days.
  7. 7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months
  8. 8. History of clinically significant other diseases that may limit or complicate participation in the study.

Contacts and Locations

Study Contact

Kevin Crawford
CONTACT
19198552145
k.crawford@tenaxthera.com
Douglas Hay, PhD
CONTACT
19198552110
d.hay@tenaxthera.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of California
Irvine, California, 92868
United States
UC Davis Health Medical Center
Sacramento, California, 95817
United States
University of California- Davis Medical Center
Sacramento, California, 95817
United States
University of California
San Francisco, California, 94143
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Winter Haven Hospital
Winter Haven, Florida, 33881
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60208
United States
University of Chicago
Chicago, Illinois, 60637
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Ascension Medical Group
Indianapolis, Indiana, 46260
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
U. of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
St. Louis Heart and Vascular
Saint Louis, Missouri, 63136
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Weill Cornell Medicine
New York, New York, 10021
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Ohio Health Research Institute
Columbus, Ohio, 43214
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health Cardiology
Columbia, South Carolina, 29203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Tech Physicians of El Paso
El Paso, Texas, 79905
United States
Revival Research Institute
Sherman, Texas, 75092
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Tenax Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-01-10
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • HFpEF
  • Pulmonary hypertension group 2
  • PH-HFpEF

Additional Relevant MeSH Terms

  • Pulmonary Hypertension