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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-008985
    NCT ID: NCT03154476
    Sponsor Protocol Number: 16-008985

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Katherine Peterson

(507)284-3642

Peterson.Katherine1@mayo.edu

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CLS-20317437

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