Eplerenone in Systemic Right Ventricle
Information source: Hospital Universitari Vall d'Hebron Research Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transposition of the Great Vessels With Atrial Switch.
Intervention: Eplerenone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hospital Universitari Vall d'Hebron Research Institute Official(s) and/or principal investigator(s):
Laura Dos, MD, Principal Investigator, Affiliation: Hospital Universitari Vall d'Hebron
Overall contact:
Laura Dos, MD, Phone: (+34) 93 274 60 00, Ext: 3191, Email: ldos@vhebron.net
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.
Clinical Details
Official title: Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Right ventricular mass assessed by cardiac-magnetic resonance
Secondary outcome: Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Laura Dos, MD, Phone: (+34) 93 274 60 00, Ext: 3191, Email: ldos@vhebron.net
Hospital Universitari de la Vall d'Hebron, Barcelona 08035, Spain; Recruiting
Laura Dos, MD, Phone: (+34) 93 274 60 00, Ext: 3191, Email: ldos@vhebron.net
Jaume Casaldaliga, MD, Phone: (+34) 93 489 31 35, Email: jcasalda@vhebron.net
Jaume Casaldaliga, MD, Sub-Investigator
Antonia Pijuan, MD, Sub-Investigator
Laura Dos, MD, Principal Investigator
Additional Information
Starting date: July 2008
Ending date: December 2010
Last updated: August 19, 2009
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