Eplerenone in Systemic Right Ventricle - Full Text View

Purpose

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	Intervention	Phase
Transposition of the Great Vessels With Atrial Switch.	Drug: Eplerenone	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.

Resource links provided by NLM:

Drug Information available for: Eplerenone

Genetic and Rare Diseases Information Center resources: Transposition of the Great Arteries

U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:

Right ventricular mass assessed by cardiac-magnetic resonance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Enrollment:	26
Study Start Date:	July 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703352

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 Universitari Vall d'Hebron

More Information

No publications provided by Hospital Universitari Vall d'Hebron Research Institute

Additional 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
Study First Received:	June 20, 2008
Last Updated:	November 30, 2011
Health Authority:	Spain: Spanish Agency of Medicines

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 Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital Heart Diseases Eplerenone Cardiovascular Agents Diuretics	Diuretics, Potassium Sparing Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mineralocorticoid Receptor Antagonists Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

Eplerenone in Systemic Right Ventricle (EVEDES)