Sildenafil Tested for Early Lung Blood Vessel Problems in Scleroderma
Tests sildenafil against a placebo in adults with scleroderma and mildly high lung pressures.
Plain-language title generated from the registry record
Registry title: Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Key facts
- Where
- Baltimore and New Orleans, United StatesSee the 2 sites
- Phase
- Phase 2
Where in United States
- Johns HopkinsBaltimore, United StatesTaking people
- Louisiana State UniversityNew Orleans, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT04797286
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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 or computed tomography with intravenous contrast (CT angiogram) without evidence of chronic thromboembolism at anytime before study entry; Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination; Informed consent.
Exclusion: Systolic blood pressure less than 90 mmHg at screening visit prior to enrollment; Enrollment in a clinical trial or concurrent use of another investigational drug (non FDA approved) or device therapy within 30 days of screening visit; Use of Pulmonary Arterial Hypertension (PAH) therapy (prostacyclin analogues, endothelin-1 receptor antagonists,phosphodiesterase-5 inhibitors, riociguat, selexipag) within the past 3 months; Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction < 45% on most recent echocardiography (within 1 year); Renal failure (creatinine above 2.0) at screening visit; Age < 18; World Health Organization (WHO) Class IV functional status; Clinically significant untreated sleep apnea; Hospitalized or acutely ill; Currently pregnant; Current use of nitrates.