Phase
Condition
Heart Failure
Circulation Disorders
Vascular Diseases
Treatment
TNX-103
Placebo
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 qualifyinghemodynamics
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/spermdonation
Exclusion
Exclusion Criteria:
A diagnosis of PH WHO Groups 1, 3, 4, or 5.
Echocardiographic evidence for hypertrophic cardiomyopathy, restrictivecardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrativecardiomyopathy
Structural heart repair or replacement of the aortic valve or mitral valve (surgicalor percutaneous). OR, planned valve intervention. OR, the presence of significantvalve disease
A diagnosis of pre-existing lung disease
History of severe allergic or anaphylactic reaction or hypersensitivity to theexcipients 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 complicateparticipation in the study.
Study Design
Study Description
Connect with a study center
St. Boniface Hospital
Winnipeg, Manitoba
CanadaActive - Recruiting
Tenax Investigational Site
Winnipeg, Manitoba
CanadaActive - Recruiting
London Health Sciences Center
London, Ontario N6A 5A5
CanadaActive - Recruiting
Tenax Investigational Site
London, Ontario N6A 5A5
CanadaActive - Recruiting
Tenax Investigational Site
Toronto, Ontario M5A 4P5
CanadaActive - Recruiting
Tenax Investigational Site
Birmingham, Alabama 35233
United StatesActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Tenax Investigational Site
Tucson, Arizona 85721
United StatesActive - Recruiting
Tenax Investigational Site
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Tenax Investigational Site
Irvine, California 92868
United StatesActive - Recruiting
University of California
Irvine, California 92868
United StatesActive - Recruiting
University of California, Irvine
Irvine, California 92868
United StatesActive - Recruiting
Tenax Investigational Site
La Jolla, California 92037
United StatesActive - Recruiting
Tenax Investigational Site
Los Angeles, California 90048
United StatesActive - Recruiting
Tenax Investigational Site
Sacramento, California 95817
United StatesActive - Recruiting
UC Davis Health Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
University of California- Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
Tenax Investigational Site
San Francisco, California 94143
United StatesActive - Recruiting
University of California
San Francisco, California 94143
United StatesActive - Recruiting
University of California, San Francisco- Heart and Vascular Center
San Francisco, California 94143
United StatesActive - Recruiting
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Tenax Investigational Site
Washington DC, District of Columbia 20010
United StatesActive - Recruiting
Mato Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic
Jacksonville, Florida 32224
United StatesActive - Recruiting
Tenax Investigational Site
Jacksonville, Florida 32224
United StatesActive - Recruiting
Tenax Investigational Site
Tampa, Florida 33612
United StatesActive - Recruiting
Tenax Investigational Site
Winter Haven, Florida 33881
United StatesActive - Recruiting
Winter Haven Hospital
Winter Haven, Florida 33881
United StatesActive - Recruiting
Emory University Hospital
Atlanta, Georgia 30322
United StatesActive - Recruiting
Tenax Investigational Site
Atlanta, Georgia 30322
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60208
United StatesActive - Recruiting
Tenax Investigational Site
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Tenax Investigational Site
Galesburg, Illinois 61401
United StatesActive - Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois 60453
United StatesActive - Recruiting
Tenax Investigational Site
Oak Lawn, Illinois 60453
United StatesActive - Recruiting
Ascension Medical Group
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Indiana University School of Medicine
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Tenax Investigational Site
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Tenax Investigational Site
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesActive - Recruiting
Tenax Investigational Site
Louisville, Kentucky 40202
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Tenax Investigational Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Tenax Investigational Site
Detroit, Michigan 48202
United StatesActive - Recruiting
M Health Fairview; U. of Minnesota Medical Center, East Bank
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Tenax Investigational Site
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
U. of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
St. Louis Heart and Vascular
Saint Louis, Missouri 63136
United StatesSite Not Available
Tenax Investigational Site
St. Louis, Missouri 63136
United StatesActive - Recruiting
Tenax Investigational Site
Omaha, Nebraska 68198
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Tenax Investigational Site
New York, New York 10021
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10021
United StatesActive - Recruiting
Tenax Investigational Site
Rochester, New York 14621
United StatesActive - Recruiting
Tenax Investigational Site
Roslyn, New York 11576
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
Tenax Investigational Site
Durham, North Carolina 27710
United StatesActive - Recruiting
Moses H. Cone Memorial Hospital
Greensboro, North Carolina 27401
United StatesActive - Recruiting
Moses H. Cone Memorial Hospital Operating Corp; Cone Health
Greensboro, North Carolina 27401
United StatesActive - Recruiting
Tenax Investigational Site
Greensboro, North Carolina 27401
United StatesActive - Recruiting
Tenax Investigational Site
Cincinnati, Ohio 45267
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United StatesActive - Recruiting
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesActive - Recruiting
Tenax Investigational Site
Columbus, Ohio 43214
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Tenax Investigational Site
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Tenax Investigational Site
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Tenax Investigational Site
Providence, Rhode Island 02903
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Tenax Investigational Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
Prism Health Cardiology
Columbia, South Carolina 29203
United StatesActive - Recruiting
Prisma Health Cardiology
Columbia, South Carolina 29203
United StatesSite Not Available
Tenax Investigational Site
Greenville, South Carolina 29605
United StatesActive - Recruiting
Tenax Investigational Site
Nashville, Tennessee 37232
United StatesActive - Recruiting
Tenax Investigational Site
Dallas, Texas 75204
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
Texas Tech Physicians of El Paso
El Paso, Texas 79905
United StatesSite Not Available
Tenax Investigational Site
Lubbock, Texas 79430
United StatesActive - Recruiting
Tenax Investigational Site
Plano, Texas 75093
United StatesActive - Recruiting
Revival Research Institute
Sherman, Texas 75092
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84107
United StatesActive - Recruiting
Tenax Investigational Site
Murray, Utah 84107
United StatesActive - Recruiting
Tenax Investigational Site
Richmond, Virginia 23298
United StatesActive - Recruiting
Tenax Investigational Site
Madison, Wisconsin 53792
United StatesActive - Recruiting
University of Wisconsin Hospital
Madison, Wisconsin 53792
United StatesActive - Recruiting
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