Eplerenone in Systemic Right Ventricle (EVEDES)
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ClinicalTrials.gov Identifier: NCT00703352 |
Recruitment Status
:
Completed
First Posted
: June 23, 2008
Last Update Posted
: March 22, 2017
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Transposition of Great Vessels Atrial Switch Procedure | Drug: Eplerenone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial. |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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.
|
- Right ventricular mass assessed by cardiac-magnetic resonance [ Time Frame: 1 year ]
- Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703352
Spain | |
Hospital Universitari de la Vall d'Hebron | |
Barcelona, Spain, 08035 |
Principal Investigator: | Laura Dos, MD | Hospital Vall d'Hebron |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT00703352 History of Changes |
Other Study ID Numbers: |
EudraCT: 2007-002605-53 |
First Posted: | June 23, 2008 Key Record Dates |
Last Update Posted: | March 22, 2017 |
Last Verified: | March 2017 |
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 Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Eplerenone Spironolactone |
Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |