NCT04797286 Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
| NCT ID | NCT04797286 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Scleroderma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-09-20 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2021-09-20 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Stephen Mathai, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT04797286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scleroderma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04797286 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04797286 currently recruiting?
Yes, NCT04797286 is actively recruiting participants. Contact the research team at smathai4@jhmi.edu for enrollment information.
Where is the NCT04797286 trial being conducted?
This trial is being conducted at New Orleans, United States, Baltimore, United States.
Who is sponsoring the NCT04797286 clinical trial?
NCT04797286 is sponsored by Johns Hopkins University. The principal investigator is Stephen Mathai, MD at Johns Hopkins University. The trial plans to enroll 30 participants.