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Sponsors and Collaborators: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Pfizer |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00703352 |
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 |
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. |
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 |
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1: Active Comparator
Eplerenone
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Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months.
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2: Placebo Comparator
Placebo
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Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Spain | |
Hospital Universitari de la Vall d'Hebron | |
Barcelona, Spain, 08035 |
Principal Investigator: | Laura Dos, MD | Hospital de la Santa Creu i de Sant Pau |
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 |
Transposition of the great arteries. Transposition of the great vessels. Mustard. Senning. |
Transposition of great arteries Eplerenone Heart Diseases Cardiovascular Abnormalities Transposition of Great Vessels |
Mechlorethamine Great vessels transposition Congenital Abnormalities Heart Defects, Congenital |
Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Pharmacologic Actions |