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Sildenafil Versus Placebo for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS): Protocol for a Randomized Controlled Trial
Background
Pulmonary hypertension (PH) is a leading cause of death in patients with systemic sclerosis (SSc). Early detection and treatment of PH is crucial for SSc patient management. The SEPVADIS trial aims to investigate the potential benefits of PH-specific therapy in SSc patients with mildly elevated pressure (SSc-MEP, mPAP 21-24 mmHg).
Methods
The SEPVADIS trial is a randomized, double-blind, placebo-controlled phase 2 trial of sildenafil in SSc-MEP patients. The primary outcome is the change in six-minute walk distance after 16 weeks of treatment. Secondary endpoints include changes in pulmonary arterial compliance and right ventricular function, as well as measurements of echocardiography, serum N-terminal probrain natriuretic peptide, and health-related quality of life at 16 and 52 weeks.
Discussion
The SEPVADIS trial will be the first randomized study of sildenafil in SSc-MEP patients. The results will inform a phase 3 study to investigate the efficacy of treating patients with mild elevations in mPAP.
Trial Registration
ClinicalTrials.gov Identifier NCT04797286.
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