Trial · NCT03154476
Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
NCT03154476, Phase 3, Completed, Mayo Clinic; results first posted 2021-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study. Trials, record NCT03154476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03154476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
- NCT number
- NCT03154476
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Cirrhosis, Congenital Heart Disease
- Interventions
- Sildenafil, Placebo
- First posted
- 2017-05-16
- Last updated
- 2021-08-23
- Results first posted
- 2021-07-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Baseline, 12 months (52 weeks), 24 months (104 weeks) | Measured using magnetic resonance imaging derived liver stiffness (MRE-LS) reported in kilopascal (kPa). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Baseline, 12 months (52 weeks), 24 months (104 weeks) | kPa | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Sildenafil | Baseline | 5.69 | Standard Deviation 0.73 | kPa |
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Placebo | Baseline | 5.72 | Standard Deviation 0.83 | kPa |
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Sildenafil | 52 weeks | 5.02 | Standard Deviation 0.94 | kPa |
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Placebo | 52 weeks | 5.68 | Standard Deviation 0.74 | kPa |
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Sildenafil | 104 weeks | 4.67 | Standard Deviation 0.86 | kPa |
| Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Placebo | 104 weeks | 5.74 | Standard Deviation 0.84 | kPa |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil | 10 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | Sildenafil | 6 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Sildenafil | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | Sildenafil | 0 | 10 |
| Total, other adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | Sildenafil | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sildenafil vs Placebo: deaths from any cause | Trial comparisons |
| Sildenafil vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT03154476
GET https://conductscience.org/api/trials/v1/NCT03154476/registered