Sotatercept in Pulmonary Arterial Hypertension (NCT07140484) | Clinical Trial Compass
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Canada27 participantsStarted 2025-10-06
Plain-language summary
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.
Participants will be asked to:
* Take Sotatercept every 21 days (±3 days)
* Each participant will be enrolled in the study for 29 Weeks
* Visit the clinic 18 times
* Have a physical exam
* Perform assessments of lung function and exercise tests
* Have an ultrasound of their heart
* Have blood draws done at regular intervals
The main objectives of the study are:
Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.
Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.
Who can participate
Age range
18 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
. Age ≥ 18 years.
. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:
. Symptomatic PAH classified as WHO FC II or III.
. On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).
. Females of childbearing potential must:
. Male participants must:
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.
. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
. Ability to understand and provide written informed consent.
Exclusion criteria
. 1\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
. Musculoskeletal limitation that precludes participation in cycle ergometry
. Resting oxygen saturation \< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
. Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
. Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period.
. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during a screening visit after a period of rest.
. Baseline systolic blood pressure \< 90 mmHg at screening.