NCT03154476: SiFALD

Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study

Completed Phase 3 Results posted Last updated 23 August 2021

What this trial tests

Phase 3 trial testing Sildenafil in Cirrhosis in 20 participants. Completed in 30 June 2019.

Timeline

5 July 2017

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	20
Start date	5 July 2017
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Sildenafil (sildenafil) — full drug profile →
• Placebo

Conditions studied

• Cirrhosis — all drugs for Cirrhosis →
• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Cirrhosis or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) Primary · Baseline, 12 months (52 weeks), 24 months (104 weeks)

Measured using magnetic resonance imaging derived liver stiffness (MRE-LS) reported in kilopascal (kPa).

Baseline

Group	Value	95% CI
Sildenafil	5.69	± 0.73
Placebo	5.72	± 0.83

52 weeks

Group	Value	95% CI
Sildenafil	5.02	± 0.94
Placebo	5.68	± 0.74

104 weeks

Group	Value	95% CI
Sildenafil	4.67	± 0.86
Placebo	5.74	± 0.84

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.