Trial · NCT04797286
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months | Baseline and 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. |
| Secondary | Difference in change in distance walked in 6MWT at 12 months | Baseline and 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. |
| Secondary | Difference in change in right ventricular function as assessed by cardiac MRI | Baseline and 4 months | As assessed by change in right ventricular function (normal/abnormal) on cardiac MRI. |
| Secondary | Difference in change in right ventricular function as assessed by cardiac MRI | Baseline and 12 months | As assessed by change in right ventricular function (normal/abnormal) on cardiac MRI. |
| Secondary | Difference in change in right ventricular function as assessed by invasive hemodynamics | Baseline and 4 months | As assessed by change in right ventricular function (normal/abnormal) on invasive hemodynamics. |
| Secondary | Difference in change in right ventricular function as assessed by invasive hemodynamics | Baseline and 12 months | As assessed by change in right ventricular function (normal/abnormal) on invasive hemodynamics. |
| Secondary | Difference in change in right ventricular function as assessed by echocardiography | Baseline and 4 months | As assessed by change in right ventricular function (normal/abnormal) on echocardiography. |
| Secondary | Difference in change in right ventricular function as assessed by echocardiography | Baseline and 12 months | As assessed by change in right ventricular function (normal/abnormal) on echocardiography. |
| Secondary | Difference in change in N-terminal pro b-type natriuretic peptide level | Baseline, 4 months and 12 months | 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. |
| Secondary | Difference in change in health related quality of life as assessed by the 36-Item Short Form Health Survey (SF36) questionnaire | Baseline, 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. |
| Secondary | Difference in change in health related quality of life as assessed by the emPHasis-10 health-related quality of life questionnaire (emPHasis-10). | Baseline, 4 months and 12 months | 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). |
| Secondary | Difference in safety profile as assessed by frequency of adverse events | Ongoing until study closes, up to 4 years | As assessed by frequency of adverse events between sildenafil and placebo groups. |
| Secondary | Difference in safety profile as assessed by severity of adverse events | Ongoing until study closes, up to 4 years | As assessed by severity of adverse events between sildenafil and placebo groups. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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