Pulmonary Arterial Hypertension (PAH)Phase 3NCT06941441
PAH Exercise Study
A Phase 3 study testing Home exercise program in people with Pulmonary Arterial Hypertension (PAH) and Exercise Therapy, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Exercise Therapy
- What is being tested?
- Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Claire E Child, DPT, MPH, 206-616-8601, pah-study@uw.edu
About this 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
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.
- Being tested
- Home exercise program
- Keywords
- PAH, pulmonary arterial hypertension, sotatercept, exercise
- Medical subject headings
- Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise programOther
A tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring
| Study group | Role | What they receive |
|---|---|---|
| Exercise Arm | Experimental | Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: 18 months
Adherence and Completion Rate
Measured: 18 months
Study-related adverse events (SAE) rate
Measured: 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
Measured: 18 months
Secondary outcomes (5)
Change from baseline in Six Minute Walk Test (6MWT) distance
Via Six Minute Walk Test administered during baseline and final in-person study visits
Measured: 24 weeks
Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT
Cardiac Effort to be calculated from Six Minute Walk Test administered during baseline and final in-person study visits
Measured: 24 weeks
Change from baseline in nT-proBNP
Via bloodwork during baseline and final in-person study visits
Measured: 24 weeks
Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)
Measured: 24 weeks
Health-related quality of life (QoL)
As measured by the PAH-specific survey PAH-SYMPACT®
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Beth Brown, University of Washington
- Investigators
- Mary Beth Brown, PT, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941441
- Sponsor's protocol ID
- STUDY00021808
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study
- ClinicalTrials.gov ID
- NCT06941441
- Acronym / sponsor ID
- STUDY00021808
- Keywords
- PAH, pulmonary arterial hypertension, sotatercept, exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Arm | Experimental | Other: Home exercise programPatients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home exercise programA tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring | Other | Exercise Arm |
Primary outcome
Recruitment rate
Time frame: 18 months
Adherence and Completion Rate
Time frame: 18 months
Study-related adverse events (SAE) rate
Time frame: 18 months
Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)'
Time frame: 18 months
Patient self-administered via the digital fitness platform with remote monitoring at two interim assessment timepoints
5 secondary outcomes
Change from baseline in Six Minute Walk Test (6MWT) distance
Time frame: 24 weeks
Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT
Time frame: 24 weeks
Change from baseline in nT-proBNP
Time frame: 24 weeks
Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)
Time frame: 24 weeks
Health-related quality of life (QoL)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Beth Brown, PT, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home exercise program in people with Pulmonary Arterial Hypertension (PAH) and Exercise Therapy, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire E Child, DPT, MPH (206-616-8601, cechild@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.