Actively Recruiting
Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension Initiating Sotatercept Therapy: A Single-site Feasibility Study
Led by University of Washington · Updated on 2025-04-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of sotatercept combined with a home exercise program for patients with pulmonary arterial hypertension (PAH) who are stable and ready to begin sotatercept therapy. This single-site study aims to assess the feasibility and functional outcomes associated with this combined intervention over a 24-week period. The study is led by the University of Washington and focuses on improving exercise capacity and quality of life in PAH patients. Participants will receive sotatercept as prescribed along with a tailored, progressive home exercise program monitored remotely using a wrist-worn fitness tracker and oxygen saturation device. The intervention period lasts 24 weeks, during which patients follow the exercise program with ongoing remote monitoring to support adherence and safety. Throughout the study, researchers will track recruitment and adherence rates, monitor study-related adverse events, and evaluate the fidelity of remote assessments such as the Six Minute Walk Test (6MWT). They will also measure changes in exercise capacity, cardiac effort, blood biomarkers, physical activity levels, and health-related quality of life. The total study duration for participants is 26 weeks, including all assessments and monitoring.
CONDITIONS
Brief Title
PAH Exercise Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of WHO Group 1 pulmonary arterial hypertension by right heart catheterization, including idiopathic, heritable, drug/toxin-induced, connective tissue disease associated, or congenital shunt repaired at least 1 year prior
- Symptomatic pulmonary hypertension classified as WHO functional class II or III
- Baseline right heart catheterization during screening showing pulmonary vascular resistance of 5 Wood units or higher and pulmonary capillary wedge pressure or left ventricular end-diastolic pressure of 15 mmHg or lower
- Stable background therapy for pulmonary arterial hypertension for more than 90 days and planned continuation during the trial
- Clinical indication to start sotatercept therapy
- Willing and able to participate in a remotely monitored home exercise program for 24 weeks
- Ability to follow study visit schedule and comply with protocol requirements
- Ability to understand and provide written informed consent
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Specific PAH Group 1 subtypes excluded: HIV-associated PAH, portal hypertension-associated PAH, schistosomiasis-associated PAH, pulmonary veno-occlusive disease
- Hemoglobin above gender-specific upper limit of normal at screening
- Platelet count below 50,000/mm3 at screening
- Uncontrolled systemic hypertension (systolic blood pressure over 160 mmHg or diastolic over 100 mmHg) or systolic blood pressure below 90 mmHg at screening
- Pregnant or breastfeeding females
- Abnormal liver or kidney function tests outside normal range
- Participation in other investigational drug studies within 30 days for small molecules or 5 half-lives for biologics prior to consent
- Prior use or known allergy to sotatercept or luspatercept
- History of full lung removal (pneumonectomy)
- Started or planned to start a structured exercise program within 90 days before or during the study
- History of portal hypertension or chronic liver disease including active hepatitis B or C
- Significant cardiac history including certain cardiomyopathies, recent cardiac procedures or events, low left ventricular ejection fraction, symptomatic coronary disease within 6 months
- Recent cerebrovascular accident within 3 months
- Acute heart failure within 14 days prior to screening
- Significant mitral or aortic valve regurgitation
- Received intravenous inotropes within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants follow a tailored, progressive home exercise program remotely monitored with a wrist-worn fitness tracker and oxygen saturation monitoring while initiating sotatercept therapy.
Regular remote monitoring with exercise tracking
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
C
Claire E Child, DPT, MPH
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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