Actively Recruiting
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Led by Johns Hopkins University · Updated on 2025-10-15
30
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
L
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous documentation of mean pulmonary artery pressure between 21 and 24 mm Hg with pulmonary capillary wedge pressure or left ventricular end-diastolic pressure 6 15 mm Hg within six months before study entry
- Diagnosis of scleroderma according to 2013 ACR/EULAR classification criteria
- Pulmonary function tests with FEV1/FVC >50% AND either TLC or FVC >70% predicted or TLC or FVC between 60% and 70% predicted with no more than mild interstitial lung disease on chest CT scan within 6 months
- Ventilation perfusion scan or CT angiogram without evidence of chronic thromboembolism at any time before study entry
- Ability to perform six minute walk test without significant musculoskeletal or coordination limitations
- Informed consent
You will not qualify if you...
- WHO Class IV functional status
- Systolic blood pressure less than 90 mmHg at screening
- Clinically significant untreated sleep apnea
- Left-sided valvular disease more than moderate or ejection fraction <45% on recent echocardiography
- Use of pulmonary arterial hypertension therapy within the past 3 months
- Hospitalized or acutely ill
- Renal failure with creatinine above 2.0 at screening
- Enrollment in another clinical trial or use of investigational drug/device within 30 days
- Age under 18
- Currently pregnant
- Current use of nitrates
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Louisiana State University
New Orleans, Louisiana, United States, 70806
Not Yet Recruiting
2
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Stephen Mathai, MD
CONTACT
R
Renee Ofori
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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