What this study is
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.
What's being tested
- Sildenafil
Intervention · DRUG
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.
- Placebo
Intervention · OTHER
Oral pill placebo.
Study details
- Sponsor
- Johns Hopkins University
- Conditions
- Scleroderma · Mildly Elevated Pulmonary Pressures
- Enrolling
- 30 people
- Starts
- 2021-09-20
- Est. completion
- 2026-11-01
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openLouisiana State University
New Orleans, Louisiana, United States
- Matthew Lammi, MD · Contact504-568-4634
- Marie Sandi · Contactmchild@lsuhsc.edu
- Matthew Lammi, MD · Principal investigator
Not yet recruitingJohns Hopkins
Baltimore, Maryland, United States
- Stephen Mathai, MD · Contact410-614-6311smathai4@jhmi.edu
- Dezeray Dutton · Contact4435078222dcephas1@jhu.edu
- Stephen Mathai, MD · Principal investigator
Recruiting
Study team
Sponsor
Johns Hopkins University
Study ID IRB00265164
Principal investigator
Stephen Mathai, MD
Johns Hopkins University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.