The following is a summary of “Sildenafil Versus Placebo for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS): protocol for a randomized controlled trial,” published in the April 2024 issue of Pulmonology by Lammi et al.
Pulmonary hypertension (PH) stands as a significant cause of mortality among patients with systemic sclerosis (SSc), underscoring the critical need for early detection and management. With the redefined threshold for PH diagnosis set at a mean pulmonary artery pressure (mPAP) > 20 mmHg, even mildly elevated pressures (SSc-MEP, mPAP 21–24 mmHg) warrant attention. However, the efficacy of PH-specific therapy in SSc-MEP patients remains uncertain.
The SEPVADIS trial, a randomized, double-blind, placebo-controlled phase 2 study, seeks to address this gap by evaluating the effects of sildenafil in patients with SSc-MEP. Enrolling 30 patients from two academic sites in the United States, the trial’s primary endpoint is the change in six-minute walk distance after 16 weeks of treatment. Secondary endpoints encompass alterations in pulmonary arterial compliance by right heart catheterization and right ventricular function by cardiac magnetic resonance imaging at the same interval.
Further assessments include echocardiography, serum N-terminal probrain natriuretic peptide, and health-related quality of life measurements at both 16 and 52 weeks. The findings from the SEPVADIS trial are poised to inform subsequent phase 3 investigations, offering valuable insights into the therapeutic management of SSc-MEP patients with mild elevations in mPAP.
Source: bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-02892-3