Taking people in United StatesPhase 2
Sildenafil Tested for Early Lung Blood Vessel Problems in Scleroderma
Tests sildenafil against a placebo in adults with scleroderma and mildly high lung pressures.
Key facts
- Who runs it
- Johns Hopkins University
- Where
- Baltimore and New Orleans, United StatesSee the 2 sites
- Trial code
- Registry title
- Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 30 people, planned
- Started
- 20 Sept 2021
- Planned end
- 1 Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Sildenafil
- Placebo
- Record updated
- 28 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with scleroderma (SSc) who have mildly raised pressure in the lung blood vessels. It tests sildenafil against a placebo.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Scleroderma (SSc) by 2013 ACR/EULAR criteria, with mean pulmonary artery pressure between 21 and 24 mm Hg and wedge pressure 15 mm Hg or lower, documented within 6 months before entry. Lung function tests must meet set limits.
- Earlier treatment
- No pulmonary arterial hypertension (PAH) therapy in the past 3 months. No nitrates now. No other investigational drug or device within 30 days of screening.
Main reasons for not taking part
- WHO Class IV functional status
- Systolic blood pressure under 90 mmHg at screening
- Pregnant now
- Hospitalized or acutely ill
- Kidney failure (creatinine above 2.0) at screening
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- Johns HopkinsBaltimore, United StatesContact: Stephen Mathai, MDTaking people
- Louisiana State UniversityNew Orleans, United StatesContact: Matthew Lammi, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SildenafilTreatment being tested
Sildenafil 20 mg by mouth three(3) times each day
- PlaceboPlacebo, for comparison
Placebo by mouth three(3) times each day
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
- Plain-language title
- Sildenafil Tested for Early Lung Blood Vessel Problems in SclerodermaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 September 2026