Phase
Condition
Vascular Diseases
Congestive Heart Failure
Pulmonary Arterial Hypertension
Treatment
Placebo
TNX-103
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
CanadaSite Not Available
Tenax Investigational Site
Winnipeg 6183235, Manitoba 6065171
CanadaActive - Recruiting
London Health Sciences Center
London, Ontario N6A 5A5
CanadaActive - Recruiting
Tenax Investigational Site
London, Ontario N6A 5A5
CanadaSite Not Available
Tenax Investigational Site
Toronto, Ontario M5A 4P5
CanadaSite Not Available
Tenax Investigational Site
London 6058560, Ontario 6093943 N6A 5A5
CanadaActive - Recruiting
Tenax Investigational Site
Toronto 6167865, Ontario 6093943 M5A 4P5
CanadaActive - Recruiting
Tenax Investigational Site
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Tenax Investigational Site
Tucson, Arizona 85721
United StatesSite Not Available
Tenax Investigational Site
Tucson 5318313, Arizona 5551752 85721
United StatesActive - Recruiting
Tenax Investigational Site
Little Rock, Arkansas 72205
United StatesSite Not Available
Tenax Investigational Site
Irvine, California 92868
United StatesSite Not Available
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 StatesSite Not Available
Tenax Investigational Site
Los Angeles, California 90048
United StatesSite Not Available
Tenax Investigational Site
Sacramento, California 95817
United StatesSite Not Available
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 StatesSite Not Available
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
Tenax Investigational Site
Torrance, California 90502
United StatesSite Not Available
Tenax Investigational Site
La Jolla 5363943, California 5332921 92037
United StatesActive - Recruiting
Tenax Investigational Site
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Tenax Investigational Site
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
Tenax Investigational Site
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Tenax Investigational Site
Torrance 5403022, California 5332921 90502
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 StatesSite Not Available
Mato Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic
Jacksonville, Florida 32224
United StatesActive - Recruiting
Tenax Investigational Site
Jacksonville, Florida 32224
United StatesSite Not Available
Tenax Investigational Site
Tampa, Florida 33601
United StatesSite Not Available
Tenax Investigational Site
Winter Haven, Florida 33881
United StatesSite Not Available
Winter Haven Hospital
Winter Haven, Florida 33881
United StatesActive - Recruiting
Tenax Investigational Site
Jacksonville 4160021, Florida 4155751 32224
United StatesActive - Recruiting
Tenax Investigational Site
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting
Tenax Investigational Site
Winter Haven 4178552, Florida 4155751 33881
United StatesActive - Recruiting
Emory University Hospital
Atlanta, Georgia 30322
United StatesActive - Recruiting
Tenax Investigational Site
Atlanta, Georgia 30322
United StatesSite Not Available
Tenax Investigational Site
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60208
United StatesActive - Recruiting
Tenax Investigational Site
Chicago, Illinois 60208
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Tenax Investigational Site
Galesburg, Illinois 61401
United StatesSite Not Available
Advocate Christ Medical Center
Oak Lawn, Illinois 60453
United StatesActive - Recruiting
Tenax Investigational Site
Oak Lawn, Illinois 60453
United StatesSite Not Available
Tenax Investigational Site
Chicago 4887398, Illinois 4896861 60208
United StatesActive - Recruiting
Tenax Investigational Site
Galesburg 4893392, Illinois 4896861 61401
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 StatesSite Not Available
Tenax Investigational Site
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Tenax Investigational Site
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Tenax Investigational Site
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesActive - Recruiting
Tenax Investigational Site
Louisville, Kentucky 40202
United StatesSite Not Available
Tenax Investigational Site
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Tenax Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
Tenax Investigational Site
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Tenax Investigational Site
Detroit, Michigan 48202
United StatesSite Not Available
M Health Fairview; U. of Minnesota Medical Center, East Bank
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Tenax Investigational Site
Minneapolis, Minnesota 55455
United StatesSite Not Available
U. of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Tenax Investigational Site
Minneapolis 5037649, Minnesota 5037779 55455
United StatesActive - Recruiting
Tenax Investigational Site
Rochester 5043473, Minnesota 5037779 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 StatesSite Not Available
Tenax Investigational Site
St Louis 4407066, Missouri 4398678 63136
United StatesActive - Recruiting
Tenax Investigational Site
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Tenax Investigational Site
Omaha 5074472, Nebraska 5073708 68198
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Tenax Investigational Site
New York, New York 10021
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10021
United StatesActive - Recruiting
Tenax Investigational Site
Rochester, New York 14621
United StatesSite Not Available
Tenax Investigational Site
Roslyn, New York 11576
United StatesSite Not Available
Tenax Investigational Site
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Tenax Investigational Site
Rochester 5134086, New York 5128638 14621
United StatesActive - Recruiting
Tenax Investigational Site
Roslyn 5134415, New York 5128638 11576
United StatesActive - Recruiting
Tenax Investigational Site
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
Tenax Investigational Site
Durham, North Carolina 27710
United StatesSite Not Available
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 StatesSite Not Available
Tenax Investigational Site
Charlotte 4460243, North Carolina 4482348 28203
United StatesActive - Recruiting
Tenax Investigational Site
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
Tenax Investigational Site
Greensboro 4469146, North Carolina 4482348 27401
United StatesActive - Recruiting
Tenax Investigational Site
Cincinnati, Ohio 45267
United StatesSite Not Available
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 StatesSite Not Available
Tenax Investigational Site
Cincinnati 4508722, Ohio 5165418 45267
United StatesActive - Recruiting
Tenax Investigational Site
Columbus 4509177, Ohio 5165418 43214
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Tenax Investigational Site
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Tenax Investigational Site
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Tenax Investigational Site
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesActive - Recruiting
Tenax Investigational Site
Providence, Rhode Island 02903
United StatesSite Not Available
Tenax Investigational Site
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Tenax Investigational Site
Charleston, South Carolina 29425
United StatesSite Not Available
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 StatesSite Not Available
Tenax Investigational Site
Charleston 4574324, South Carolina 4597040 29425
United StatesActive - Recruiting
Tenax Investigational Site
Columbia 4575352, South Carolina 4597040 29044
United StatesActive - Recruiting
Tenax Investigational Site
Nashville, Tennessee 37232
United StatesSite Not Available
Tenax Investigational Site
Dallas, Texas 75390
United StatesSite Not Available
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 StatesSite Not Available
Tenax Investigational Site
Plano, Texas 75093
United StatesSite Not Available
Revival Research Institute
Sherman, Texas 75092
United StatesSite Not Available
Tenax Investigational Site
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
Tenax Investigational Site
Lubbock 5525577, Texas 4736286 79430
United StatesActive - Recruiting
Tenax Investigational Site
Plano 4719457, Texas 4736286 75093
United StatesActive - Recruiting
Intermountain Medical Center
Murray, Utah 84107
United StatesActive - Recruiting
Tenax Investigational Site
Murray, Utah 84107
United StatesSite Not Available
Tenax Investigational Site
Murray 5778755, Utah 5549030 84107
United StatesActive - Recruiting
Tenax Investigational Site
Richmond, Virginia 23298
United StatesSite Not Available
Tenax Investigational Site
Richmond 4781708, Virginia 6254928 23298
United StatesActive - Recruiting
Tenax Investigational Site
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Hospital
Madison, Wisconsin 53792
United StatesActive - Recruiting
Tenax Investigational Site
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting

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