Back to search results

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

This study is testing if sildenafil (Viagra), a drug approved for pulmonary arterial hypertension (high blood pressure in the lungs), can help people with scleroderma (a disease that hardens skin and organs) who have mildly elevated pulmonary pressures. You might be able to join if you have scleroderma and your mean pulmonary artery pressure is between 21 and 24 mm Hg. The study will measure success by seeing if participants can walk further in a 6-minute walk test after 4 months. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is a Phase II, randomized, double-blind (meaning neither you nor your doctor will know if you're receiving the drug or placebo), placebo-controlled study. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 months, comparing changes from your baseline measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04797286

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Johns Hopkins University
~30 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:SildenafilPlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months
Measured over Baseline and 4 months

Conditions

Scleroderma
Mildly Elevated Pulmonary Pressures

Explore related trials

Pulmonary HypertensionScleroderma

Where it's being run

2 sites across 2 states
Louisiana1
Maryland1

Study leadership

  • Stephen Mathai, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Stephen Mathai, MD
[email protected]
4106146311
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

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

World Health Organization (WHO) Class IV functional status.
Systolic blood pressure less than 90 mmHg at screening visit prior to enrollment.
Clinically significant untreated sleep apnea.
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).
Use of Pulmonary Arterial Hypertension (PAH) therapy (prostacyclin analogues, endothelin-1 receptor antagonists,phosphodiesterase-5 inhibitors, riociguat, selexipag) within the past 3 months.
Hospitalized or acutely ill.
Renal failure (creatinine above 2.0) at screening visit.
Enrollment in a clinical trial or concurrent use of another investigational drug (non FDA approved) or device therapy within 30 days of screening visit.
Age \< 18.
Currently pregnant.
Current use of nitrates.

What this trial measures

  • Difference in change in distance walked in 6 minute walk test (6MWT) at 4 monthsBaseline and 4 months

    As assessed by change in 6 minute walk distance (6MWD) in feet (from baseline to 4 months) between the sildenafil group and the placebo group.