Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
SEPVADIS
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2021
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
October 15, 2025
October 1, 2025
5 years
March 11, 2021
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in change in distance walked in 6 minute walk test (6MWT) at 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.
Baseline and 4 months
Secondary Outcomes (12)
Difference in change in distance walked in 6MWT at 12 months
Baseline and 12 months
Difference in change in right ventricular function as assessed by cardiac MRI
Baseline and 4 months
Difference in change in right ventricular function as assessed by cardiac MRI
Baseline and 12 months
Difference in change in right ventricular function as assessed by invasive hemodynamics
Baseline and 4 months
Difference in change in right ventricular function as assessed by invasive hemodynamics
Baseline and 12 months
- +7 more secondary outcomes
Study Arms (2)
Sildenafil
EXPERIMENTALSildenafil 20 mg by mouth three(3) times each day
Placebo
PLACEBO COMPARATORPlacebo by mouth three(3) times each day
Interventions
Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Louisiana State University
New Orleans, Louisiana, 70806, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Related Publications (1)
Lammi MR, Mukherjee M, Saketkoo LA, Carey K, Hummers L, Hsu S, Krishnan A, Sandi M, Shah AA, Zimmerman SL, Hassoun PM, Mathai SC. Sildenafil Versus Placebo for Early Pulmonary Vascular Disease in Scleroderma (SEPVADIS): protocol for a randomized controlled trial. BMC Pulm Med. 2024 Apr 30;24(1):211. doi: 10.1186/s12890-024-02892-3.
PMID: 38689245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Mathai, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Study Start
September 20, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
October 15, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share