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Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.
BACKGROUND: There is no clinical evidence supporting medical treatment for the failing systemic right ventricle in patients with transposition of the great vessels with atrial switch. Cardiac magnetic resonance studies have shown a significant degree of myocardial fibrosis in right ventricles in the systemic position, which predisposes to systolic and diastolic dysfunction. Aldosterone is a widely recognized neurohormonal marker involved in the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown a decrease in ventricular mass in hypertensive patients, presumably related to reduction of myocardial fibrosis. HYPOTHESIS: Low dose of eplerenone, a selective mineralocorticoid receptor blocker, in patients with systemic right ventricle can reduce the ventricular mass by means of a reduction in myocardial fibrosis, resulting in improved systolic function. PATIENTS AND METHODS: Randomized, double blind, parallel clinical trial comparing eplerenone (50mg daily) with placebo. Study population: Adult patients (\>18 years) diagnosed with repaired transposition of the great arteries with atrial switch (Senning or Mustard techniques) routinely followed at a tertiary referral center. Duration: 12 months. Outcomes: Right ventricular mass, myocardial fibrosis mass and ejection fraction assessed by cardiac magnetic resonance.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitari de la Vall d'Hebron
Barcelona, Barcelona, Spain
Start Date
July 1, 2008
Primary Completion Date
December 1, 2010
Completion Date
December 1, 2010
Last Updated
March 22, 2017
26
ACTUAL participants
Eplerenone
DRUG
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
NCT05809310
NCT03049540
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