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 range18 Years
SexALL
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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:
✓. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
✓. Ability to understand and provide written informed consent.
. 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.