Eplerenone in Systemic Right Ventricle

Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703352

Acronym

EVEDES

Enrollment

Registered

2008-06-23

Start date

2008-07-31

Completion date

2010-12-31

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Switch Procedure, Transposition of Great Vessels

Keywords

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

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.

Interventions

DRUGEplerenone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Right ventricular mass assessed by cardiac-magnetic resonance	1 year

Secondary

Measure	Time frame
Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance	1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026