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A 24-Week Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF) (the APEX Study)
EU CTIS ID: 2024-514283-40-00
What this study is testing
To evaluate the effect of TX000045 vs placebo on mean PVR in participants with baseline PVR ≥3 Wood units. To evaluate the safety of TX000045 in participants with PH-HFpEF
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Is a male or female of non–childbearing potential between the ages of 18 and 83 years.
- 2. Has a diagnosis of PH-HFpEF based on ALL the following criteria: a) The baseline echocardiogram, performed during screening, demonstrates the following: left ventricular ejection fraction (LVEF) >40%, tricuspid regurgitation gradient peak >36 mm Hg, and SPAP >41 mm Hg.
- 3. Has NYHA functional class II-III heart failure
- 4. Has 6MWT distance ≥100 m and ≤450 m, repeated during screening.
- 5. If the participant is receiving chronic medication for the treatment of heart failure, including diuretics, or any other cardiovascular condition (including systemic hypertension), the dose must be stable for ≥30 days before start of screening.
You likely can't join if
- 1. Has a confirmed diagnosis of PH in WHO Group 1 (pulmonary arterial hypertension), WHO Group 3 (PH associated with significant lung disease), WHO Group 4 (PH associated with chronic thromboembolic disease), or WHO Group 5
- 2. Was hospitalized for any indication within 7 days before the start of screening
- 20. Is pregnant or breastfeeding
- 22. Has a history of active malignancy within 5 years before the start of screening, except for fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or squamous cell carcinomas of the skin
- 23. Has a history of drug or alcohol abuse
- 24. Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy
See the full eligibility criteria
Who can join
- 1. Is a male or female of non–childbearing potential between the ages of 18 and 83 years.
- 2. Has a diagnosis of PH-HFpEF based on ALL the following criteria: a) The baseline echocardiogram, performed during screening, demonstrates the following: left ventricular ejection fraction (LVEF) >40%, tricuspid regurgitation gradient peak >36 mm Hg, and SPAP >41 mm Hg.
- 3. Has NYHA functional class II-III heart failure
- 4. Has 6MWT distance ≥100 m and ≤450 m, repeated during screening.
- 5. If the participant is receiving chronic medication for the treatment of heart failure, including diuretics, or any other cardiovascular condition (including systemic hypertension), the dose must be stable for ≥30 days before start of screening.
What rules you out
- 1. Has a confirmed diagnosis of PH in WHO Group 1 (pulmonary arterial hypertension), WHO Group 3 (PH associated with significant lung disease), WHO Group 4 (PH associated with chronic thromboembolic disease), or WHO Group 5
- 2. Was hospitalized for any indication within 7 days before the start of screening
- 20. Is pregnant or breastfeeding
- 22. Has a history of active malignancy within 5 years before the start of screening, except for fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or squamous cell carcinomas of the skin
- 23. Has a history of drug or alcohol abuse
- 24. Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy
- 25. Has significant orthopedic or arthritic disease that limits the ability to complete a 6MWT
- 26. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator
- 27. Has a history of any illness that, in the opinion of the investigator, poses additional risk to the participant
- 3. Received IV vasoactive therapies inotropes
- 5. Initiated a new exercise program within 90 days before the start of screening or plans to initiate such a program during the study (patients who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
- Has documented significant lung disease
- 6. Has a body mass index (BMI) <18 kg/m2 or >50 kg/m2
- 7. Was previously administered TX000045, relaxin, or a relaxin fusion protein
- 8. Received a small molecule RXFP1 agonist within 30 days before the start of screening
- 11. Has cardiovascular comorbidities
- Has chronic liver disease (other than congestive hepatopathy), active hepatitis B infection (positive hepatitis B surface antigen and positive hepatitis B core antibodies), or hepatitis C infection (positive hepatitis C antibodies) at the screening visit. In patients with isolated positive hepatitis B core antibodies, a hepatitis B DNA test will be performed. If positive, the participant will be excluded from the study due to active hepatitis B.
- 14. Has HIV infection or HIV seropositivity at the screening visit
- 15. Has an active tuberculosis infection
- 16. Has any of the following clinical laboratory values during screening: a) Serum alanine aminotransferase or aspartate aminotransferase levels >3× the upper limit of normal (ULN) or total bilirubin >3× ULN b) Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD EPI [Chronic Kidney Disease Epidemiology Collaboration] equation) or required renal replacement therapy (eg, ultrafiltration or dialysis) within 90 days before the start of screening c) HbA1c (glycosylated hemoglobin) >9% d) Platelet count <50,000/mm3 e) Hemoglobin <10.0g/dL
- 17. Has a history of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product
- 18. Had major surgery within 60 days before the start of screening.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Serbia
- Armenia
- Moldova, Republic of
- Georgia
- Ukraine
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Serbia; Armenia; Moldova, Republic of; Georgia; Ukraine and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.