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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Eplerenone in Systemic Right Ventricle | |||
| Official Title ICMJE | Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial. | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months. | |||
| Study Arms ICMJE |
| |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 26 | |||
| Original Estimated Enrollment ICMJE | 90 | |||
| Actual Study Completion Date ICMJE | December 2010 | |||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Spain | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00703352 | |||
| Other Study ID Numbers ICMJE | EudraCT: 2007-002605-53 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Hospital Universitari Vall d'Hebron Research Institute | |||
| Study Sponsor ICMJE | Hospital Universitari Vall d'Hebron Research Institute | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Hospital Universitari Vall d'Hebron Research Institute | |||
| Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||