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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Alexander Egbe, M.B.B.S., M.P.H.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Egbe, M.B.B.S., M.P.H.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials