Tetralogy of Fallot Clinical Trial
Official title:
Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Hypothesis:
By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the
great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident
heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias
decreased through decreases in myocardial fibrosis.
Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6
minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months
without therapy, after 6 months on therapy, then finally after 12 months of eplerenone
therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12
months on therapy. Patients will be randomly assigned to drug free period up front versus at
the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated
up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at
enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for
monitoring.
n/a
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