Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
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.
| Condition(s) | Scleroderma, Mildly Elevated Pulmonary Pressures |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Previous documentation of mean pulmonary artery pressure between 21 and 24 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) ≤ 15 mm Hg within six months before study entry. * Diagnosis of SSc according to 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria. * Pulmonary function tests with forced expiratory volume in one second/forced vital capacity (FEV1/FVC) \>50% AND either a) total lung capacity (TLC) or forced vital capacity (FVC) \> 70% predicted or b) TLC or FVC between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest on studies obtained within 6 months of enrollment. * Ventilation perfusion scan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | New Orleans, Louisiana, United States; Baltimore, Maryland, United States |
| Start date | 2021-09-20 |
| NCT ID | NCT04797286 |
| Official listing | https://clinicaltrials.gov/study/NCT04797286 |