PAH Exercise Study with Sotatercept

This study is looking at how a home exercise program, along with the medication sotatercept, affects people with Pulmonary Arterial Hypertension (PAH). PAH is a serious condition where blood pressure in the arteries leading to your lungs is too high. You might be able to join if you are at least 18 years old, have a confirmed diagnosis of certain types of PAH, and are stable enough to start sotatercept. The study aims to see how many people join, how well they stick to the exercise program, and if there are any study-related side effects over 18 months. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design: This is an interventional study involving 10 participants. It is not specified if it is randomized or blinded.
What's involved: You would participate in a 26-week study, including a 24-week period where you receive sotatercept and follow a tailored home exercise program using a fitness tracker and oxygen monitor.
Compensation: Not stated in the trial record.
Follow-up: The study measures outcomes like recruitment rate and adverse events at 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

PAH Exercise Study

Recruiting

PHASE3Ages 18+InterventionalTreatment

University of Washington

~10 participants

Updated 2025-04-23 on ClinicalTrials.gov

What's tested:Home exercise program

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Recruitment rate

Measured over 18 months

+3 more outcomes measured

Conditions

Pulmonary Arterial Hypertension (PAH)

Exercise Therapy

NCT06941441

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of Washington
Seattle, Washingtonstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Mary Beth Brown, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Claire E Child, DPT, MPH

[email protected]

206-616-8601

Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

Recruitment rate18 months
Adherence and Completion Rate18 months
Study-related adverse events (SAE) rate18 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

Trialytics