Actively Recruiting
Sotatercept in Pulmonary Arterial Hypertension
Led by University of Alberta · Updated on 2026-05-06
27
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
M
Merck Canada Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sotatercept in Pulmonary Arterial Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of pulmonary arterial hypertension (Group 1) confirmed by right heart catheterization
- Diagnosis includes idiopathic, heritable, drug/toxin-induced PAH, PAH associated with connective tissue disease, or PAH after repair of simple congenital shunts for at least 1 year
- Symptomatic PAH classified as WHO Functional Class II or III
- On stable doses of two or more background PAH therapies for at least 60 days before screening
- Females of childbearing potential must have negative pregnancy tests before treatment, use effective contraception during the study and for 16 weeks after, and not breastfeed or donate blood or eggs during this time
- Male participants must use condoms during sexual contact with females of childbearing potential during the study and for 16 weeks after, and not donate blood or sperm during this time
- Ability to follow study visit schedule and understand protocol requirements
- Ability to provide written informed consent
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Musculoskeletal limitations preventing participation in cycle ergometry
- Resting oxygen saturation below 88% (unless maintained ≥88% after 3 minutes off oxygen)
- PAH subtypes including HIV-associated, portal hypertension-associated, schistosomiasis-associated, or pulmonary veno-occlusive disease
- Hemoglobin above gender-specific upper limit of normal at screening
- Platelet count below 50,000/mm3 at enrollment
- Uncontrolled systemic hypertension (systolic >160 mmHg or diastolic >100 mmHg) during screening
- Systolic blood pressure below 90 mmHg at screening
- Pregnant or breastfeeding women
- Estimated glomerular filtration rate below 30 mL/min/m2
- Liver enzymes or bilirubin levels more than 3 times the upper limit of normal (except Gilbert's syndrome)
- Participation in other investigational drug studies recently (within 30 days for small molecules or 5 half-lives for biologics)
- History of full pneumonectomy
- Pulmonary function test values below 60% predicted forced vital capacity or abnormal FEV1/FVC
- Smoking history of 20 pack-years or more or smoking/vaping within 3 months
- Body mass index of 40 kg/m2 or higher
- Planned start of cardiopulmonary rehabilitation exercise program during study
- History of portal hypertension or chronic liver disease including recent hepatitis B or C infection
- History of restrictive, constrictive, or congestive cardiomyopathy
- Atrial septostomy within 180 days prior to screening
- ECG with corrected QT interval over 500 ms
- Personal or family history of long QT syndrome or sudden cardiac death
- Left ventricular ejection fraction below 45% within 6 months prior to screening
- Recent symptomatic coronary disease events within 6 months prior to screening
- Stroke within 3 months prior to screening
- Significant mitral or aortic valve dysfunction
- Use of intravenous inotropes within 30 days prior to screening
- Known allergy to sotatercept or any of its components
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Trial Site Locations
Total: 1 location
1
Clinical Physiology Laboratory
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
Research Team
D
Desi Fuhr, MSc
CONTACT
K
Kostia Dmytriiev, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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