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SclerodermaPhase 2SEPVADISNCT04797286

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

A Phase 2 study testing Sildenafil in people with Scleroderma and Mildly Elevated Pulmonary Pressures, run by Johns Hopkins University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sildenafil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
20 Sep 2021to 1 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen Mathai, MD contact

4106146311

smathai4@jhmi.edu

Renee Ofori contact

410-614-6311

rofori2@jhu.edu

United States2 sites, 2 recruiting

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Stephen Mathai, MD, 410-614-6311, smathai4@jhmi.edu

    Dezeray Dutton, 4435078222, dcephas1@jhu.edu

    Recruiting

  • Louisiana State University

    New Orleans, Louisiana, 70806

    Matthew Lammi, MD, 504-568-4634

    Marie Sandi, mchild@lsuhsc.edu

    Not yet recruiting

Other trials in United States

About this study

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.

Read the detailed description

Data shows that sildenafil (SIL) is an effective therapy in SSc-PAH. SIL has been safely used in many patients with various vascular and cardiovascular diseases over the past three decades. Randomized controlled trial data for SIL shows improvement in 6MWD, hemodynamics, and even evidence of cardiac remodeling in PAH and SSc-PAH patients. Based upon these data, SIL may be an effective therapy in SSc-MEP. This study will help determine whether sildenafil could be a good treatment for patients with scleroderma that have mildly elevated pulmonary pressures.

Being tested
Sildenafil, Placebo
Keywords
SSc-MEP
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SildenafilDrug

    Also called Revatio, Viagra

    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.

  • PlaceboOther

    Oral pill placebo.

Study groups in NCT04797286
Study groupRoleWhat they receive
SildenafilExperimentalSildenafil 20 mg by mouth three(3) times each day
Receives: Drug: Sildenafil
PlaceboPlacebo comparatorPlacebo by mouth three(3) times each day
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 4 months

Secondary outcomes (12)

  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.

    Measured: Baseline and 12 months

  2. 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.

    Measured: Baseline and 4 months

  3. 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.

    Measured: Baseline and 12 months

  4. 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.

    Measured: Baseline and 4 months

  5. 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.

    Measured: Baseline and 12 months

  6. Difference in change in right ventricular function as assessed by echocardiography

    As assessed by change in right ventricular function (normal/abnormal) on echocardiography.

    Measured: Baseline and 4 months

  7. Difference in change in right ventricular function as assessed by echocardiography

    As assessed by change in right ventricular function (normal/abnormal) on echocardiography.

    Measured: Baseline and 12 months

  8. Difference in change in N-terminal pro b-type natriuretic peptide level

    As assessed by changes in plasma N-terminal pro b-type natriuretic peptide (NT-proBNP) level (pg/mL) between sildenafil and placebo groups at four months and twelve months.

    Measured: Baseline, 4 months and 12 months

  9. Difference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaire

    As assessed by changes in SF36 questionnaire between sildenafil and placebo groups at four months and twelve months. The SF36 yields a set of scaled scores in 8 domains, with higher numbers representing a better quality of life. Each scale is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.

    Measured: Baseline, 4 months and 12 months

  10. Difference in change in health related quality of life as assessed by the emPHasis-10 health-related quality of life questionnaire (emPHasis-10).

    As assessed by changes in emPHasis-10 questionnaire between sildenafil and placebo groups. The Emphasis 10 score consists of 10 questions scored in a semantic 6-point scale (from 0 to 5), for a total maximum score of 50 (the higher the score, the worse the quality of life).

    Measured: Baseline, 4 months and 12 months

  11. Difference in safety profile as assessed by frequency of adverse events

    As assessed by frequency of adverse events between sildenafil and placebo groups.

    Measured: Ongoing until study closes, up to 4 years

  12. Difference in safety profile as assessed by severity of adverse events

    As assessed by severity of adverse events between sildenafil and placebo groups.

    Measured: Ongoing until study closes, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start20 Sep 2021
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797286
Sponsor's protocol ID
IRB00265164
Acronym
SEPVADIS
Status last verified
Sep 2026
First submitted
11 Mar 2021
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38689245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sildenafil in people with Scleroderma and Mildly Elevated Pulmonary Pressures, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephen Mathai, MD (4106146311, smathai4@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04797286, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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