Phase 3
N=20
Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
Cirrhosis · Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT03154476 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) — 5.69; 5.72; 5.02; 5.68 kPa
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sildenafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Stiffness as Measured by Magnetic Resonance Elastography (MRE) |
5.69; 5.72; 5.02; 5.68; 4.67; 5.74 | — |
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.
Eligibility Criteria
Inclusion criteria
- All adult Fontan patients who have no contraindications for magnetic resonance imaging (MRI) will be eligible for the study.
Exclusion criteria
- Subjects with implantable pacemakers
- Residual cardiac lesions (severe ventricular dysfunction, severe atrioventricular valve regurgitation, Fontan baffle or conduit obstruction)
- Viral hepatitis
- Severe renal dysfunction
- History of sildenafil use in the six months prior to study enrollment
- Ongoing sildenafil therapy
- Patients currently taking nitrates
- Hypotension at baseline (BP <90/50 mmHg)
- Pulmonary veno-occlusive disease
- Hearing/vision impairment
- Pulmonary hypertension due to sickle cell disease
- Women of child-bearing potential with a positive pregnancy test will additionally be excluded
Data sourced from ClinicalTrials.gov (NCT03154476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.