Eplerenone in Systemic Right Ventricle (EVEDES)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Transposition of Great Vessels; Atrial Switch Procedure	Drug: Eplerenone	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	26 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.
Study Start Date :	July 2008
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; Eplerenone	Drug: Eplerenone; Eplerenone (coated tablet) 50mg daily during 12 months.
Placebo Comparator: 2; Placebo	Drug: Eplerenone; Eplerenone (coated tablet) 50mg daily during 12 months.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Right ventricular mass assessed by cardiac-magnetic resonance [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adult patients (>18 years old)
• Diagnosis of transposition of the great arteries repaired with atrial switch procedures (Mustard or Senning).
• Regular follow up at tertiary referral center.

Exclusion Criteria:

• Concomitant disease with life expectancy <1 year.
• Inclusion in heart transplant waiting list.
• Basal serum creatinine level > 1.5 mg/dl.
• Basal serum potassium level > 5.0 mmol/L.
• Intolerance to the investigational medical product.
• Treatment with spironolactone or eplerenone within the previous 6 months.
• Inability to undergo magnetic resonance imaging.
• Pregnancy or breast feeding.
• Denial of informed consent.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
Hospital Universitari de la Vall d'Hebron
Barcelona, Spain, 08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Pfizer

Investigators

Principal Investigator:	Laura Dos, MD	Hospital Vall d'Hebron

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dos L, Pujadas S, Estruch M, Mas A, Ferreira-González I, Pijuan A, Serra R, Ordóñez-Llanos J, Subirana M, Pons-Lladó G, Marsal JR, García-Dorado D, Casaldàliga J. Eplerenone in systemic right ventricle: double blind randomized clinical trial. The evedes study. Int J Cardiol. 2013 Oct 15;168(6):5167-73. doi: 10.1016/j.ijcard.2013.07.163. Epub 2013 Jul 25.

Responsible Party:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT00703352 History of Changes
Other Study ID Numbers:	EudraCT: 2007-002605-53
First Posted:	June 23, 2008
Last Update Posted:	March 22, 2017
Last Verified:	March 2017

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:

Transposition of the great arteries.; Transposition of the great vessels.; Mustard.; Senning.

Additional relevant MeSH terms:

Transposition of Great Vessels; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Eplerenone; Spironolactone	Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents