Eplerenone in Systemic Right Ventricle

NCT00703352 | Completed Phase 4 DMC

• 1 other identifier: EudraCT: 2007-002605-53
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Transposition of Great Vessels; Atrial Switch Procedure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Right ventricular mass assessed by cardiac-magnetic resonance

  1 year

Secondary Outcomes (1)

• Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Eplerenone

Drug: Eplerenone

2

PLACEBO COMPARATOR

Placebo

Drug: Eplerenone

Interventions

Eplerenone DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Concomitant disease with life expectancy \<1 year.
• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

Hospital Universitari de la Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (1)

• Dos L, Pujadas S, Estruch M, Mas A, Ferreira-Gonzalez I, Pijuan A, Serra R, Ordonez-Llanos J, Subirana M, Pons-Llado G, Marsal JR, Garcia-Dorado D, Casaldaliga 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.

  PMID: 23972966 DERIVED

MeSH Terms

Conditions

Transposition of Great Vessels

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Laura Dos, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

ES (1)