A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Prese… (NCT06616974) | Clinical Trial Compass
RecruitingPhase 2
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
United States, Armenia, Australia180 participantsStarted 2024-09-04
Plain-language summary
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).
Who can participate
Age range
18 Years – 83 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (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 dose prior to screening.
. Is able to understand and provide documented consent for participation.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Timeframe: Baseline up to Week 24 post first dose
2
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
Timeframe: Baseline up to Week 30 post first dose
3
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Timeframe: Baseline up to Week 30 post first dose
4
Number of participants with treatment-related adverse events.
Timeframe: Baseline up to Week 30 post first dose
5
Number of participants with changes in the physical examination findings.
. 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-specific therapies, or a relaxin receptor agonist.
. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate 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 such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
. Has any of the following clinical laboratory values during screening: