Eplerenone in Systemic Right Ventricle - Full Text View

Sponsors and Collaborators:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Pfizer
Information provided by:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT00703352

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 IV

Drug Information available for: Aldosterone Mechlorethamine Mechlorethamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

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 ]

Estimated Enrollment:	90
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Eplerenone	Drug: Eplerenone Eplerenone (coated tablet) 50mg daily during 12 months.
2: Placebo Comparator 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

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

Contacts

Contact: Laura Dos, MD	(+34) 93 291 90 00 ext 5945	laura_dos_subira@hotmail.com
Contact: Jaume Casaldaliga, MD	(+34) 93 489 31 35	jcasalda@vhebron.net

Locations

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

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Pfizer

Investigators

Principal Investigator:

Laura Dos, MD

Hospital de la Santa Creu i de Sant Pau

More Information

Responsible Party:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau ( Jordi Varela Pedragosa )
Study ID Numbers:	EudraCT: 2007-002605-53
Study First Received:	June 20, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703352
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

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

Study placed in the following topic categories:

Transposition of great arteries
Eplerenone
Heart Diseases
Cardiovascular Abnormalities
Transposition of Great Vessels

Mechlorethamine
Great vessels transposition
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:

Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009