Actively Recruiting
PAH Exercise Study
Led by University of Washington · Updated on 2025-04-23
10
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ten patients with PAH who are stable and eligible to initiate sotatercept therapy will participate in a 26 week study that consists of a 24-week intervention period where patients will receive complimentary sotatercept as prescribed, plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring.
CONDITIONS
Official Title
PAH Exercise Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Confirmed WHO Group 1 PAH diagnosis by right heart catheterization
- Symptomatic PH classified as WHO Functional Class II or III
- Baseline right heart catheterization showing PVR 65 5 WU and PCWP or left ventricular end-diastolic pressure 64 15 mmHg
- Stable PAH background therapy for more than 90 days
- Clinical indication to initiate sotatercept therapy
- Willing and able to participate in a remotely-monitored home exercise program for 24 weeks
- Able to comply with study visits and protocol requirements
- Able to understand and provide written informed consent
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- HIV-associated PAH, PAH with portal hypertension, schistosomiasis-associated PAH, or pulmonary veno-occlusive disease
- Hemoglobin above gender-specific upper limit at screening
- Platelet count below 50,000/mm3 at screening
- Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg) or low systolic BP (< 90 mmHg) at screening
- Pregnant or breastfeeding females
- Abnormal liver or kidney function tests
- Participation in another investigational drug study within 30 days or biologics within 5 half-lives prior to consent
- Prior exposure or allergic reaction to sotatercept or luspatercept
- History of full pneumonectomy
- Started or planned structured exercise program within 90 days
- History of portal hypertension or chronic liver disease, including active hepatitis B or C
- Cardiac history including restrictive or congestive cardiomyopathy, recent atrial septostomy, prolonged QT interval, family history of long QT syndrome, low left ventricular ejection fraction, or recent symptomatic coronary disease
- Stroke within 3 months prior to screening
- Acute decompensated 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
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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
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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