Health TrialsbyHealthPanel

PAH Exercise Study

ConditionsPulmonary Arterial Hypertension (PAH)Exercise Therapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Home exercise program

    Other intervention

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Exercise ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Time frame
18 months
2

Adherence and Completion Rate

Time frame
18 months
3

Study-related adverse events (SAE) rate

Time frame
18 months
4

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

Time frame
18 months

Secondary outcomes

1

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

Via Six Minute Walk Test administered during baseline and final in-person study visits

Time frame
24 weeks
2

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

Time frame
24 weeks
3

Change from baseline in nT-proBNP

Via bloodwork during baseline and final in-person study visits

Time frame
24 weeks
4

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

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Source ClinicalTrials.gov
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