At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Sildenafil +1 moredrug
Likely dose
Sildenafil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
In Brief
A Phase 3 clinical trial evaluating Sildenafil and Placebo for Cirrhosis and Congenital Heart Disease. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if the medication, sildenafil (also known as Revatio), can slow or stop the progression of liver disease in patients who previously had a Fontan operation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis, Congenital Heart Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartJul 2017
Primary CompletionJun 2019
TodayJul 2026
First PostedMay 16, 2017
Enrollment StartJul 5, 2017
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.1 years ago
Interventions
Sildenafildrug
Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.
Placebodrug
Placebo capsules matching study drug