Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Description

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.

Conditions

Scleroderma, Mildly Elevated Pulmonary Pressures

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Study Overview

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Study Details

Study overview

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.

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

Condition
Scleroderma
Intervention / Treatment

-

Contacts and Locations

New Orleans

Louisiana State University, New Orleans, Louisiana, United States, 70806

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Stephen Mathai, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-09