APEX Study: TX000045 for Pulmonary Hypertension with Heart Failure
This study, called APEX, is testing a new drug called TX000045 for people with pulmonary hypertension (high blood pressure in the lungs) caused by heart failure with preserved ejection fraction (HFpEF, meaning your heart pumps blood well but is stiff). We want to see if TX000045 can improve how well your lungs and heart work together. You might receive TX000045 at two different doses, or a placebo (an inactive substance). The study will look at changes in your lung blood vessel resistance and track any side effects. To join, you need to be between 18 and 83 years old, have a diagnosis of PH-HFpEF, and have certain heart failure symptoms. The study aims to enroll about 191 participants. The current recruitment status is unclear.
- Study design
- This is a double-blind, randomized, parallel group, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving TX000045 or placebo. Approximately 191 participants will be enrolled.
- What's involved
- You will receive subcutaneous injections (under the skin) every 2 or 4 weeks for 24 weeks. You will have assessments at baseline and up to 30 weeks after your first dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 weeks after your first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
At a glance
Conditions
Where it's being run
72 sites across 39 statesStudy leadership
- Robert Rogers, MD · STUDY_DIRECTOR · Tectonic Therapeutic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).Baseline up to Week 24 post first dose
Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
- Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.Baseline up to Week 30 post first dose
- Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.Baseline up to Week 30 post first dose
- Number of participants with treatment-related adverse events.Baseline up to Week 30 post first dose
- Number of participants with changes in the physical examination findings.Baseline to Week 30 post first dose