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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Sildenafil Citrate

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