NCT04797286RecruitingPhase 2
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Mar 2021
- Start date
- 20 Sept 2021
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04797286
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 20 Sept 2021 to the primary completion date, 1 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Use of Pulmonary Arterial Hypertension (PAH) therapy (prostacyclin analogues, endothelin-1 receptor antagonists,phosphodiesterase-5 inhibitors, riociguat, selexipag) within the past 3 months.
Lab values
- 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
- Age \< 18.
Other
- World Health Organization (WHO) Class IV functional status.
- Clinically significant untreated sleep apnea.
- Hospitalized or acutely ill.
- Currently pregnant.
- Current use of nitrates.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Louisiana State University Coordinator of this site? Confirm its status | New Orleans | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.