Phase
Condition
Heart Failure
Congestive Heart Failure
Diabetes And Hypertension
Treatment
TX000045- Dose A
TX000045- Dose B
Placebo
Clinical Study ID
Ages 18-83 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is a male or female of non-childbearing potential between the ages of 18 and 83years.
Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heartcatheterization (RHC).
Has NYHA functional class II- III heart failure.
Has 6MWT distance from 100 to 450m.
Chronic medication for heart failure or cardiovascular disease is at a stable doseprior to screening.
Is able to understand and provide documented consent for participation.
Exclusion
Exclusion Criteria:
Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
Current or recent hospitalization prior to screening.
Recently received vasoactive drugs, pulmonary arterial hypertension-specifictherapies, or a relaxin receptor agonist.
Initiated a new exercise program for cardiopulmonary rehabilitation or plans toinitiate such a program during the study.
Has a body mass index <18 kg/meter square or >45 kg/ meter square.
Was previously administered TX000045, relaxin, or a relaxin fusion protein.
Historical or current evidence of a clinically significant disease or disorder suchas significant lung disease, cardiovascular comorbitiies, liver disease, infectiousdisease, or malignancy.
Has any of the following clinical laboratory values during screening:
Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x theupper limit of normal (ULN) or total bilirubin > 3 x ULN;
eGFR <30 mL/min/1.73 m2;
HbA1c (glycosylated hemoglobin) >9%;
Platelet count <50,000/millimeter cube;
Hemoglobin <10.0g/dL;
History of hypersensitivity or reactions to drugs with a similar chemical structureor class to TX000045.
Is pregnant or breastfeeding.
Has a history of cancer within 5 years of screening other than basal cell carcinoma,cervical carcinoma, or squamous cell carcinomas of the skin.
Has a history of drug or alcohol abuse.
Was recently dosed in any clinical research study.
Study Design
Study Description
Connect with a study center
Yerevan
Yerevan, 0087
ArmeniaActive - Recruiting
Macquarie
Macquarie, New South Wales 2109
AustraliaActive - Recruiting
Westmead Hospital
Macquarie, New South Wales 2109
AustraliaSite Not Available
Sydney
Sydney, New South Wales 2010
AustraliaSite Not Available
Wollongong
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Auchenflower
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Chermside
Chermside, Queensland 4032
AustraliaActive - Recruiting
Hobart
Hobart, Tasmania 7000
AustraliaActive - Recruiting
Malvern
Malvern, Victoria 3144
AustraliaActive - Recruiting
Brussel
Brussel, 1070
BelgiumSite Not Available
Genk
Genk, 3600
BelgiumSite Not Available
Pleven
Pleven, 5800
BulgariaActive - Recruiting
Plovdiv
Plovdiv, 4001
BulgariaActive - Recruiting
Sofia
Sofia, 1750
BulgariaSite Not Available
Tbilisi
Tbilisi, 0167
GeorgiaActive - Recruiting
Hamburg
Hamburg, 20246
GermanySite Not Available
Mainz
Mainz, 55131
GermanySite Not Available
Remscheid
Remscheid, 42859
GermanySite Not Available
Riga
Riga, LV10002
LatviaSite Not Available
Chisinau
Chisinau,
Moldova, Republic ofActive - Recruiting
Christchurch
Christchurch, 8011
New ZealandActive - Recruiting
Dunedin
Dunedin, 9016
New ZealandSite Not Available
Białystok
Białystok, 15-276
PolandActive - Recruiting
Krakow
Kraków, 31-202
PolandSite Not Available
Lublin
Lublin, 20-090
PolandSite Not Available
Warsaw
Warsaw, 04-628
PolandSite Not Available
Łodź
Łódź, 91-347
PolandSite Not Available
Craiova
Craiova, 200642
RomaniaSite Not Available
Targu Mures
Târgu-Mureş, 540136
RomaniaActive - Recruiting
Barcelona
Barcelona, 08035
SpainActive - Recruiting
Madrid
Madrid, 28034
SpainActive - Recruiting
Santiago de Compostela ( Coruña )
Santiago De Compostela, 15706
SpainActive - Recruiting
Valencia
Valencia, 46015
SpainSite Not Available
Gaziantep
Gaziantep, 27310
TurkeySite Not Available
Istanbul
Istanbul, 34899
TurkeySite Not Available
Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Scottsdale
Scottsdale, Arizona 85258
United StatesActive - Recruiting
San Francisco
San Francisco, California 94143
United StatesSite Not Available
Aurora
Aurora, Colorado 80045
United StatesActive - Recruiting
Jacksonville
Jacksonville, Florida 32216
United StatesSite Not Available
Tampa
Tampa, Florida 33613
United StatesSite Not Available
Augusta
Augusta, Georgia 30912
United StatesSite Not Available
McDonough
McDonough, Georgia 30253
United StatesSite Not Available
Chicago
Chicago, Illinois 60453
United StatesSite Not Available
Covington
Covington, Louisiana 70433
United StatesActive - Recruiting
Baltimore
Baltimore, Maryland 21201
United StatesSite Not Available
Boston
Boston, Massachusetts 02180
United StatesActive - Recruiting
Jackson
Jackson, Mississippi 39216
United StatesActive - Recruiting
St Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Omaha
Omaha, Nebraska 68105
United StatesSite Not Available
New York
New York, New York 10075
United StatesSite Not Available
Durham
Durham, North Carolina 27710
United StatesSite Not Available
Toledo
Toledo, Ohio 43606
United StatesActive - Recruiting
Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
York
York, Pennsylvania 17403
United StatesSite Not Available
Rock Hill
Rock Hill, South Carolina 29732
United StatesActive - Recruiting
Nashville
Nashville, Tennessee 37205
United StatesSite Not Available
Beaumont
Beaumont, Texas 77702
United StatesActive - Recruiting
Port Arthur
Port Arthur, Texas 77642
United StatesActive - Recruiting
Waco
Waco, Texas 76712
United StatesActive - Recruiting
Salt Lake City
Salt Lake City, Utah 84112
United StatesSite Not Available
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