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Sildenafil for Early Pulmonary Vascular Disease in Scleroderma — SEPVADIS  

Scleroderma Clinical Trial

Official title:
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Clinical Trial Summary

This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.

Clinical Trial Description

Data shows that sildenafil (SIL) is an effective therapy in SSc-PAH. SIL has been safely used in many patients with various vascular and cardiovascular diseases over the past three decades. Randomized controlled trial data for SIL shows improvement in 6MWD, hemodynamics, and even evidence of cardiac remodeling in PAH and SSc-PAH patients. Based upon these data, SIL may be an effective therapy in SSc-MEP. This study will help determine whether sildenafil could be a good treatment for patients with scleroderma that have mildly elevated pulmonary pressures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04797286
Study type Interventional
Source Johns Hopkins University
Contact Stephen Mathai, MD
Phone 4106146311
Email smathai4@jhmi.edu
Status Recruiting
Phase Phase 2
Start date September 20, 2021
Completion date September 2024
View Details
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