Status:
RECRUITING
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Louisiana State University Health Sciences Center in New Orleans
United States Department of Defense
Conditions:
Scleroderma
Mildly Elevated Pulmonary Pressures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
Data shows that sildenafil (SIL) is an effective therapy in SSc-PAH. SIL has been safely used in many patients with various vascular and cardiovascular diseases over the past three decades. Randomized...
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.
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04797286
Start Date
September 20 2021
End Date
September 1 2026
Last Update
October 15 2025
Active Locations (2)
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1
Louisiana State University
New Orleans, Louisiana, United States, 70806
2
Johns Hopkins
Baltimore, Maryland, United States, 21287