Exercise program for patients with pulmonary arterial hypertension receiving sotatercept

Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study

This study is testing whether a special exercise program combined with a new medication can help people with pulmonary arterial hypertension feel better and improve their ability to exercise.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06941441 on ClinicalTrials.gov

What this trial studies

This study involves ten stable patients with pulmonary arterial hypertension (PAH) who will participate in a 26-week program combining sotatercept therapy with a tailored home exercise regimen. The intervention includes a 24-week period where patients will receive sotatercept and engage in a progressive exercise program monitored by a wrist-worn fitness tracker and oxygen saturation levels. The goal is to assess the impact of this combined approach on patient outcomes and exercise capacity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of WHO Group 1 PAH and stable on background therapy.

Not a fit: Patients with severe PAH symptoms classified as WHO FC IV or those unable to participate in a home exercise program may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve exercise capacity and overall health for patients with pulmonary arterial hypertension.

How similar studies have performed: While there have been studies on exercise in PAH, the combination of sotatercept with a structured exercise program is a novel approach.

Eligibility criteria

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

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Mary Beth Brown, PT, PhD — University of Washington
• Study coordinator: Claire E Child, DPT, MPH

Conditions Pulmonary Arterial Hypertension; Exercise Therapy; PAH; pulmonary arterial hypertension; sotatercept; exercise