Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Sildenafil
DrugSildenafil 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
Other interventionOral pill placebo.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: SildenafilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 4 monthsSecondary outcomes
1
Difference in change in distance walked in 6MWT at 12 months
As assessed by change in 6 minute walk test distance in feet (from baseline to 12 months) between the sildenafil group and the placebo group.
Time frame
Baseline and 12 months2
Difference in change in right ventricular function as assessed by cardiac MRI
As assessed by change in right ventricular function (normal/abnormal) on cardiac MRI.
Time frame
Baseline and 4 months3
Difference in change in right ventricular function as assessed by cardiac MRI
As assessed by change in right ventricular function (normal/abnormal) on cardiac MRI.
Time frame
Baseline and 12 months4
Difference in change in right ventricular function as assessed by invasive hemodynamics
As assessed by change in right ventricular function (normal/abnormal) on invasive hemodynamics.
Time frame
Baseline and 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov