NCT04797286

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Scleroderma
• Mildly Elevated Pulmonary Pressures

Interventions

Type	Name	Description
DRUG	Sildenafil	Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.
OTHER	Placebo	Oral pill placebo.

Timeline

• Start date: 2021-09-20
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-03-15
• Last updated: 2025-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study