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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cirrhosis, Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT03154476

Run by

Mayo Clinic

People needed

20

Starts

2017-07-05

Expected to finish

2019-06-30

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult Fontan patients who have no contraindications for magnetic resonance imaging (MRI) will be eligible for the study.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.