Clinical trial NCT06941441: PAH Exercise Study
Official title: Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension (PAH)
Exercise Therapy
Keywords: PAH
pulmonary arterial hypertension
sotatercept
exercise
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recruitment rate
timeFrame: 18 months
measure: Adherence and Completion Rate
timeFrame: 18 months
measure: Study-related adverse events (SAE) rate
timeFrame: 18 months
measure: Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)'
timeFrame: 18 months
Secondary outcomes:
measure: Change from baseline in Six Minute Walk Test (6MWT) distance
timeFrame: 24 weeks
measure: Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT
timeFrame: 24 weeks
measure: Change from baseline in nT-proBNP
timeFrame: 24 weeks
measure: Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)
timeFrame: 24 weeks
measure: Health-related quality of life (QoL)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mary Beth Brown, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: