Eplerenone in Systemic Right Ventricle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Transposition of Great Vessels Atrial Switch Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Eplerenone

Group Type ACTIVE_COMPARATOR

Eplerenone

Intervention Type DRUG

Eplerenone (coated tablet) 50mg daily during 12 months.

2

Placebo

Group Type PLACEBO_COMPARATOR

Eplerenone

Intervention Type DRUG

Eplerenone (coated tablet) 50mg daily during 12 months.

Interventions

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Eplerenone

Eplerenone (coated tablet) 50mg daily during 12 months.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No