PAH Exercise Study

NCT06941441 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY00021808
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension (PAH); Exercise Therapy

Keywords

PAH; pulmonary arterial hypertension; sotatercept; exercise

Outcome Measures

Primary Outcomes (4)

• 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)'

  Patient self-administered via the digital fitness platform with remote monitoring at two interim assessment timepoints

  18 months

Secondary Outcomes (5)

• Change from baseline in Six Minute Walk Test (6MWT) distance

  24 weeks

• Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT

  24 weeks

• Change from baseline in nT-proBNP

  24 weeks

• Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)

  24 weeks

• Health-related quality of life (QoL)

  24 weeks

Study Arms (1)

Exercise Arm

EXPERIMENTAL

Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring

Other: Home exercise program

Interventions

Home exercise program OTHER

A tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring

Exercise Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Mary Beth Brown, PT, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire E Child, DPT, MPH

CONTACT

206-616-8601; cechild@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)