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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Katherine Peterson

(507)284-3642

Peterson.Katherine1@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317437

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