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Trial · NCT04797286

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

NCT04797286, Phase 2, Recruiting, Johns Hopkins University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Sildenafil for Early Pulmonary Vascular Disease in Scleroderma. Trials, record NCT04797286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04797286

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
NCT number
NCT04797286
Status
Recruiting
Phases
Phase 2
Enrollment
30 participants, estimated
Lead sponsor
Johns Hopkins University
Conditions
Scleroderma, Mildly Elevated Pulmonary Pressures
Interventions
Sildenafil, Placebo
First posted
2021-03-15
Last updated
2026-09-28

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDifference in change in distance walked in 6 minute walk test (6MWT) at 4 monthsBaseline and 4 monthsAs assessed by change in 6 minute walk distance (6MWD) in feet (from baseline to 4 months) between the sildenafil group and the placebo group.
SecondaryDifference in change in distance walked in 6MWT at 12 monthsBaseline and 12 monthsAs assessed by change in 6 minute walk test distance in feet (from baseline to 12 months) between the sildenafil group and the placebo group.
SecondaryDifference in change in right ventricular function as assessed by cardiac MRIBaseline and 4 monthsAs assessed by change in right ventricular function (normal/abnormal) on cardiac MRI.
SecondaryDifference in change in right ventricular function as assessed by cardiac MRIBaseline and 12 monthsAs assessed by change in right ventricular function (normal/abnormal) on cardiac MRI.
SecondaryDifference in change in right ventricular function as assessed by invasive hemodynamicsBaseline and 4 monthsAs assessed by change in right ventricular function (normal/abnormal) on invasive hemodynamics.
SecondaryDifference in change in right ventricular function as assessed by invasive hemodynamicsBaseline and 12 monthsAs assessed by change in right ventricular function (normal/abnormal) on invasive hemodynamics.
SecondaryDifference in change in right ventricular function as assessed by echocardiographyBaseline and 4 monthsAs assessed by change in right ventricular function (normal/abnormal) on echocardiography.
SecondaryDifference in change in right ventricular function as assessed by echocardiographyBaseline and 12 monthsAs assessed by change in right ventricular function (normal/abnormal) on echocardiography.
SecondaryDifference in change in N-terminal pro b-type natriuretic peptide levelBaseline, 4 months and 12 monthsAs 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.
SecondaryDifference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaireBaseline, 4 months and 12 months
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
38689245DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04797286

GET https://conductscience.org/api/trials/v1/NCT04797286/registered