Recruiting
Phase 2

Sildenafil

Sponsor:

Johns Hopkins University

Code:

NCT04797286

Conditions

Scleroderma

Mildly Elevated Pulmonary Pressures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sildenafil

Placebo

Study Details

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.

Conditions

Scleroderma

Mildly Elevated Pulmonary Pressures

Study ID

NCT04797286

Start date

Sep 20, 2021

Status verified date

Sep, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sildenafil

Sildenafil 20 mg by mouth three(3) times each day

placebo comparator: Placebo

Placebo by mouth three(3) times each day

Interventions

Sildenafil

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

Oral pill placebo.

Primary outcome measure

  • Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months [ Time Frame: Baseline and 4 months ]

Central Contacts and Locations

Central contacts

Stephen Mathai, MD

4106146311smathai4@jhmi.edu

Renee Ofori

410-614-6311rofori2@jhu.edu

Locations

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Stephen Mathai, MD

410-614-6311smathai4@jhmi.edu

Dezeray Dutton

4435078222dcephas1@jhu.edu

Principal Investigator:

Stephen Mathai, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • SSc-MEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.