| NCT ID | NCT06941441 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Washington |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2026-09-30 |
Trial Parameters
Eligibility Fast-Check
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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 *