PAH Exercise Study
Phase 3
Recruiting
- Conditions
- Pulmonary Arterial Hypertension (PAH)Exercise Therapy
- Registration Number
- NCT06941441
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Age ≥ 18 years
- Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with CTD, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- Symptomatic PH classified as WHO FC II or III
- Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 WU and a pulmonary capillary wedge (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg
- Receiving stable background therapy for PAH for >90 days and will continue receiving throughout trial. Background treatments may consist of monotherapy, double therapy, or triple therapy with currently available medications for PAH.
- Initiation of Sotatercept is clinically indicated
- Willing and able to participate in a remotely-monitored home exercise program for 24 weeks
- 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
- Diagnosis of PH WHO Groups 2, 3, 4, or 5
- Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease
- Hemoglobin at screening above gender-specific ULN
- Baseline platelet count < 50,000/mm3 (< 50.0 × 109/L) at screening
- Uncontrolled systemic hypertension as evidenced by sitting systolic BP > 160 mmHg or sitting diastolic BP > 100 mmHg during screening visit after a period of rest; Baseline systolic BP < 90 mmHg at screening
- Pregnant or breastfeeding females
- Clinical laboratory liver and kidney function tests outside of normal range
- Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
- Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536) or known allergic reaction to either one
- History of full pneumonectomy
- Initiation of a structured exercise program within 90 days prior or planned initiation during the study
- Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).
- Cardiac related history: History of restrictive, constrictive, or congestive cardiomyopathy; History of atrial septostomy within 180 days prior to the screening visit; ECG with Fridericia's corrected QT interval (QTcF) > 500 ms during the Screening Period; Personal or family history of long QT syndrome (LQTS) or sudden cardiac death; Left ventricular ejection fraction (LVEF) < 45% on historical ECHO within 12 months prior to the screening visit; Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
- Cerebrovascular accident within 3 months prior to the screening visit
- Acutely decompensated heart failure within 14 days prior to the screening visit, as per investigator assessment
- Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Recruitment rate 18 months Adherence and Completion Rate 18 months Study-related adverse events (SAE) rate 18 months Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)' 18 months Patient self-administered via the digital fitness platform with remote monitoring at two interim assessment timepoints
- Secondary Outcome Measures
Name Time Method Change from baseline in Six Minute Walk Test (6MWT) distance 24 weeks Via Six Minute Walk Test administered during baseline and final in-person study visits
Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT 24 weeks Cardiac Effort to be calculated from Six Minute Walk Test administered during baseline and final in-person study visits
Change from baseline in nT-proBNP 24 weeks Via bloodwork during baseline and final in-person study visits
Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA) 24 weeks Health-related quality of life (QoL) 24 weeks As measured by the PAH-specific survey PAH-SYMPACT®
Trial Locations
- Locations (1)
University of Washington
🇺🇸Seattle, Washington, United States