Phase
Condition
Stress
Heart Disease
Vascular Diseases
Treatment
TX000045- Dose A
Placebo
TX000045- Dose B
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
ArmeniaSite Not Available
Yerevan
Yerevan 616052, 0087
ArmeniaActive - 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
AustraliaSite Not Available
Macquarie
Macquarie, New South Wales 2155400 2109
AustraliaActive - Recruiting
Sydney
Sydney 2147714, New South Wales 2155400 2010
AustraliaActive - Recruiting
Wollongong
Wollongong 2171507, New South Wales 2155400 2500
AustraliaActive - Recruiting
Auchenflower
Auchenflower, Queensland 4066
AustraliaSite Not Available
Chermside
Chermside, Queensland 4032
AustraliaSite Not Available
Auchenflower
Auchenflower 6943571, Queensland 2152274 4066
AustraliaActive - Recruiting
Chermside
Chermside 6943582, Queensland 2152274 4032
AustraliaActive - Recruiting
Hobart
Hobart, Tasmania 7000
AustraliaSite Not Available
Hobart
Hobart 2163355, Tasmania 2147291 7000
AustraliaActive - Recruiting
Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Malvern
Malvern 2158952, Victoria 2145234 3145
AustraliaActive - Recruiting
Camperdown
Camperdown 2172563, 2050
AustraliaActive - Recruiting
New Lambton
New Lambton 2205629, 2305
AustraliaActive - Recruiting
Austria
Vienna 2761369, 1100
AustriaSite Not Available
Brussel
Brussel, 1070
BelgiumSite Not Available
Brussel
Brussels 2800866, 1070
BelgiumActive - Recruiting
Genk
Genk, 3600
BelgiumSite Not Available
Genk
Genk 2797670, 3600
BelgiumActive - Recruiting
Pleven
Pleven, 5800
BulgariaSite Not Available
Pleven
Pleven 728203, 5800
BulgariaActive - Recruiting
Plovdiv
Plovdiv, 4001
BulgariaSite Not Available
Plovdiv
Plovdiv 728193, 4001
BulgariaActive - Recruiting
Sofia
Sofia, 1700
BulgariaSite Not Available
Sofia
Sofia 727011, 1750
BulgariaActive - Recruiting
Tbilisi
Tbilisi, 0167
GeorgiaSite Not Available
Tbilisi
Tbilisi 611717, 0167
GeorgiaActive - Recruiting
Hamburg
Hamburg, 20246
GermanySite Not Available
Mainz
Mainz, 55131
GermanySite Not Available
Mainz
Mainz 2874225, 55131
GermanyActive - Recruiting
Remscheid
Remscheid, 42859
GermanySite Not Available
Riga
Riga, LV10002
LatviaSite Not Available
Riga
Riga 456172, LV10002
LatviaActive - Recruiting
Chisinau
Chisinau 618426,
MoldovaActive - Recruiting
Chisinau
Chisinau,
Moldova, Republic ofSite Not Available
Christchurch
Christchurch, 8011
New ZealandSite Not Available
Christchurch
Christchurch 2192362, 8011
New ZealandActive - Recruiting
Dunedin
Dunedin, 9016
New ZealandSite Not Available
Dunedin
Dunedin 2191562, 9016
New ZealandActive - Recruiting
Białystok
Bialystok 776069, 15-276
PolandActive - Recruiting
Białystok
Białystok, 15-276
PolandSite Not Available
Krakow
Krakow 3094802, 31-202
PolandActive - Recruiting
Krakow
Kraków, 31-202
PolandSite Not Available
Łodź
Lodz 3093133, 91-347
PolandActive - Recruiting
Lublin
Lublin, 20-090
PolandSite Not Available
Lublin
Lublin 765876, 20-090
PolandActive - Recruiting
Warsaw
Warsaw, 04-628
PolandSite Not Available
Warsaw
Warsaw 756135, 04-628
PolandActive - Recruiting
Wrocław
Wroclaw 3081368, 50-556
PolandActive - Recruiting
Łodź
Łódź, 91-347
PolandSite Not Available
Almada
Almada 2271961, 2805-267
PortugalActive - Recruiting
Lisboa
Lisbon 2267057, 1649-028
PortugalSite Not Available
Porto
Porto 2735943, 4099-001
PortugalActive - Recruiting
Bucuresti
Bucharest 683506, 022328
RomaniaActive - Recruiting
Craiova
Craiova, 200642
RomaniaSite Not Available
Craiova
Craiova 680332, 200642
RomaniaActive - Recruiting
Targu Mures
Târgu Mureş 665004, 540136
RomaniaActive - Recruiting
Targu Mures
Târgu-Mureş, 540136
RomaniaSite Not Available
Nis, Belgrade
Belgrade 792680, Nis 18108
SerbiaActive - Recruiting
Belgrade
Belgrade 792680, 11000
SerbiaActive - Recruiting
Serbia
Belgrade 792680, 11040
SerbiaActive - Recruiting
Sremska Kamenica
Kamenitz 3190104, 21204
SerbiaActive - Recruiting
Kragujevac
Kragujevac 789128, 34000
SerbiaActive - Recruiting
Barcelona
Barcelona, 08035
SpainSite Not Available
Barcelona
Barcelona 3128760, 08035
SpainActive - Recruiting
Madrid
Madrid, 28041
SpainSite Not Available
Madrid
Madrid 3117735, 28034
SpainActive - Recruiting
Santiago de Compostela ( Coruña )
Santiago De Compostela, 15706
SpainSite Not Available
Santiago de Compostela ( Coruña )
Santiago de Compostela 3109642, 15706
SpainActive - Recruiting
Toledo
Toledo 2510409, 45007
SpainSite Not Available
Valencia
Valencia, 46015
SpainSite Not Available
Valencia
Valencia 2509954, 46010
SpainActive - Recruiting
Gaziantep
Gaziantep, 27310
TurkeySite Not Available
Istanbul
Istanbul, 34899
TurkeySite Not Available
Ukraine
Kyiv 703448, 01135
UkraineActive - Recruiting
Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Scottsdale
Scottsdale, Arizona 85258
United StatesSite Not Available
Phoenix
Phoenix 5308655, Arizona 5551752 85283
United StatesActive - Recruiting
Scottsdale
Scottsdale 5313457, Arizona 5551752 85258
United StatesActive - Recruiting
San Francisco
San Francisco, California 94143
United StatesSite Not Available
San Francisco
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Santa Rosa
Santa Rosa 5393287, California 5332921 95405
United StatesActive - Recruiting
Aurora
Aurora, Colorado 80045
United StatesSite Not Available
Aurora
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Jacksonville
Jacksonville, Florida 32216
United StatesSite Not Available
Tampa
Tampa, Florida 33613
United StatesSite Not Available
Jacksonville
Jacksonville 4160021, Florida 4155751 32216
United StatesActive - Recruiting
Tampa
Tampa 4174757, Florida 4155751 33613
United StatesActive - Recruiting
Augusta
Augusta, Georgia 30912
United StatesSite Not Available
McDonough
McDonough, Georgia 30253
United StatesSite Not Available
Augusta
Augusta 4180531, Georgia 4197000 30912
United StatesActive - Recruiting
McDonough
McDonough 4208442, Georgia 4197000 30253
United StatesActive - Recruiting
Boise
Boise 5586437, Idaho 5596512 83706
United StatesActive - Recruiting
Chicago
Chicago, Illinois 60453
United StatesSite Not Available
Chicago
Chicago 4887398, Illinois 4896861 60453
United StatesActive - Recruiting
Indianapolis
Indianapolis 4259418, Indiana 4921868 46219
United StatesActive - Recruiting
USA
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
Covington
Covington, Louisiana 70433
United StatesSite Not Available
Baltimore
Baltimore, Maryland 21201
United StatesSite Not Available
Baltimore
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Boston
Boston, Massachusetts 02180
United StatesSite Not Available
Boston
Boston 4930956, Massachusetts 6254926 02180
United StatesActive - Recruiting
Minneapolis
Minneapolis 5037649, Minnesota 5037779 55414
United StatesActive - Recruiting
Jackson
Jackson, Mississippi 39216
United StatesSite Not Available
St Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
St Louis
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Omaha
Omaha, Nebraska 68105
United StatesSite Not Available
Omaha
Omaha 5074472, Nebraska 5073708 68198
United StatesActive - Recruiting
New York
New York, New York 10075
United StatesSite Not Available
New York
New York 5128581, New York 5128638 10075
United StatesActive - Recruiting
Durham
Durham, North Carolina 27710
United StatesSite Not Available
Durham
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
Toledo
Toledo, Ohio 43606
United StatesSite Not Available
Toledo
Toledo 5174035, Ohio 5165418 43606
United StatesActive - Recruiting
Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
York
York, Pennsylvania 17403
United StatesSite Not Available
Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
York
York 4562407, Pennsylvania 6254927 17403
United StatesActive - Recruiting
Rock Hill
Rock Hill, South Carolina 29732
United StatesSite Not Available
Rock Hill
Rock Hill 4593142, South Carolina 4597040 29732
United StatesActive - Recruiting
Nashville
Nashville, Tennessee 37205
United StatesSite Not Available
Beaumont
Beaumont, Texas 77702
United StatesSite Not Available
Port Arthur
Port Arthur, Texas 77642
United StatesSite Not Available
Waco
Waco, Texas 76712
United StatesSite Not Available
Port Arthur
Port Arthur 4720039, Texas 4736286 77642
United StatesActive - Recruiting
Waco
Waco 4739526, Texas 4736286 76712
United StatesActive - Recruiting
Salt Lake City
Salt Lake City, Utah 84112
United StatesSite Not Available
Salt Lake City
Salt Lake City 5780993, Utah 5549030 84112
United StatesActive - Recruiting
United States
Norfolk 4776222, Virginia 6254928 23507
United StatesActive - Recruiting
Richmond
Richmond 4781708, Virginia 6254928 23230
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.