Actively Recruiting
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Led by Tectonic Therapeutic · Updated on 2026-03-27
180
Participants Needed
86
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
CONDITIONS
Official Title
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of non-childbearing potential aged 18 to 83 years
- Diagnosis of PH-HFpEF confirmed by echocardiogram and right heart catheterization
- NYHA functional class II or III heart failure
- Six-minute walk test distance between 100 and 450 meters
- Stable dose of chronic medication for heart failure or cardiovascular disease before screening
- Ability to understand and provide documented informed consent
You will not qualify if you...
- Diagnosis of pulmonary hypertension in WHO Groups 1, 3, 4, or 5
- Current or recent hospitalization before screening
- Recent use of vasoactive drugs, pulmonary arterial hypertension therapies, or relaxin receptor agonists
- Starting or planning to start a new cardiopulmonary rehabilitation exercise program during the study
- Body mass index less than 18 or greater than 45 kg/m2
- Previous treatment with TX000045, relaxin, or relaxin fusion protein
- Significant lung disease, cardiovascular comorbidities, liver disease, infectious disease, or cancer within 5 years (except certain skin or cervical cancers)
- Abnormal lab values during screening including liver enzymes, bilirubin, kidney function, HbA1c, platelet count, or hemoglobin
- History of hypersensitivity to drugs similar to TX000045
- Pregnancy or breastfeeding
- History of drug or alcohol abuse
- Recent participation in another clinical research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Phoenix
Phoenix, Arizona, United States, 85283
Actively Recruiting
2
Scottsdale
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Santa Rosa
Santa Rosa, California, United States, 95405
Actively Recruiting
5
Aurora
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Jacksonville
Jacksonville, Florida, United States, 32216
Actively Recruiting
7
Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
8
Augusta
Augusta, Georgia, United States, 30912
Actively Recruiting
9
McDonough
McDonough, Georgia, United States, 30253
Actively Recruiting
10
Boise
Boise, Idaho, United States, 83706
Actively Recruiting
11
Chicago
Chicago, Illinois, United States, 60453
Actively Recruiting
12
Indianapolis
Indianapolis, Indiana, United States, 46219
Actively Recruiting
13
USA
Louisville, Kentucky, United States, 40202
Actively Recruiting
14
Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
15
Boston
Boston, Massachusetts, United States, 02180
Actively Recruiting
16
Minneapolis
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
17
St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
18
Omaha
Omaha, Nebraska, United States, 68198
Actively Recruiting
19
New York
New York, New York, United States, 10029
Actively Recruiting
20
New York
New York, New York, United States, 10075
Actively Recruiting
21
Durham
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Toledo
Toledo, Ohio, United States, 43606
Actively Recruiting
23
Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
24
Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
25
York
York, Pennsylvania, United States, 17403
Actively Recruiting
26
Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
27
Port Arthur
Port Arthur, Texas, United States, 77642
Actively Recruiting
28
Waco
Waco, Texas, United States, 76712
Actively Recruiting
29
Salt Lake City
Salt Lake City, Utah, United States, 84112
Actively Recruiting
30
United States
Norfolk, Virginia, United States, 23507
Actively Recruiting
31
Richmond
Richmond, Virginia, United States, 23230
Actively Recruiting
32
Yerevan
Yerevan, Armenia, 0006
Actively Recruiting
33
Yerevan
Yerevan, Armenia, 0025
Actively Recruiting
34
Yerevan
Yerevan, Armenia, 0087
Actively Recruiting
35
Camperdown
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
36
Macquarie
Macquarie, New South Wales, Australia, 2109
Actively Recruiting
37
New Lambton
New Lambton, New South Wales, Australia, 2305
Actively Recruiting
38
Sydney
Sydney, New South Wales, Australia, 2010
Actively Recruiting
39
Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
40
Auchenflower
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
41
Chermside
Chermside, Queensland, Australia, 4032
Actively Recruiting
42
Hobart
Hobart, Tasmania, Australia, 7000
Actively Recruiting
43
Malvern
Malvern, Victoria, Australia, 3145
Actively Recruiting
44
Camperdown
Camperdown, Australia, 2050
Actively Recruiting
45
New Lambton
New Lambton, Australia, 2305
Actively Recruiting
46
Austria
Vienna, Austria, 1100
Actively Recruiting
47
Brussel
Brussels, Belgium, 1070
Actively Recruiting
48
Genk
Genk, Belgium, 3600
Completed
49
Pleven
Pleven, Bulgaria, 5800
Actively Recruiting
50
Plovdiv
Plovdiv, Bulgaria, 4001
Actively Recruiting
51
Sofia
Sofia, Bulgaria, 1700
Actively Recruiting
52
Sofia
Sofia, Bulgaria, 1750
Actively Recruiting
53
Tbilisi
Tbilisi, Tb, Georgia, 0186
Actively Recruiting
54
Tbilisi
Tbilisi, Georgia, 0159
Actively Recruiting
55
Tbilisi
Tbilisi, Georgia, 0167
Actively Recruiting
56
Tbilisi
Tbilisi, Georgia, 0191
Actively Recruiting
57
Mainz
Mainz, Germany, 55131
Actively Recruiting
58
Riga
Riga, Latvia, LV10002
Actively Recruiting
59
Chisinau
Chisinau, Moldova
Actively Recruiting
60
Christchurch
Christchurch, New Zealand, 8011
Actively Recruiting
61
Dunedin
Dunedin, New Zealand, 9016
Actively Recruiting
62
Białystok
Bialystok, Poland, 15-276
Actively Recruiting
63
Krakow
Krakow, Poland, 31-202
Actively Recruiting
64
Łodź
Lodz, Poland, 91-347
Actively Recruiting
65
Lublin
Lublin, Poland, 20-090
Actively Recruiting
66
Warsaw
Warsaw, Poland, 04-628
Actively Recruiting
67
Wrocław
Wroclaw, Poland, 50-556
Actively Recruiting
68
Almada
Almada, Portugal, 2805-267
Actively Recruiting
69
Lisboa
Lisbon, Portugal, 1649-028
Actively Recruiting
70
Porto
Porto, Portugal, 4099-001
Actively Recruiting
71
Bucuresti
Bucharest, Romania, 022328
Actively Recruiting
72
Craiova
Craiova, Romania, 200642
Actively Recruiting
73
Targu Mures
Târgu Mureş, Romania, 540136
Actively Recruiting
74
Nis, Belgrade
Belgrade, Nis, Serbia, 18108
Actively Recruiting
75
Belgrade
Belgrade, Serbia, 11000
Actively Recruiting
76
Serbia
Belgrade, Serbia, 11040
Actively Recruiting
77
Sremska Kamenica
Kamenitz, Serbia, 21204
Actively Recruiting
78
Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
79
Barcelona
Barcelona, Spain, 08035
Actively Recruiting
80
Madrid
Madrid, Spain, 28034
Actively Recruiting
81
Madrid
Madrid, Spain, 28041
Actively Recruiting
82
Santiago de Compostela ( Coruña )
Santiago de Compostela, Spain, 15706
Actively Recruiting
83
Toledo
Toledo, Spain, 45007
Actively Recruiting
84
Valencia
Valencia, Spain, 46010
Actively Recruiting
85
Valencia
Valencia, Spain, 46015
Actively Recruiting
86
Ukraine
Kyiv, Ukraine, 01135
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here