Eplerenone in Systemic Right Ventricle

NCT00703352

Last updated date
Study Location
Hospital Universitari de la Vall d'Hebron
Barcelona, , 08035, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transposition of Great Vessels, Atrial Switch Procedure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Transposition of Great Vessels, Atrial Switch ProcedureEplerenone in Systemic Right Ventricle
NCT00703352
  1. Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Transposition of Great Vessels
  • Atrial Switch Procedure
Intervention  ICMJE Drug: Eplerenone
Eplerenone (coated tablet) 50mg daily during 12 months.
Study Arms  ICMJE
  • Active Comparator: 1
    Eplerenone
    Intervention: Drug: Eplerenone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Eplerenone
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
 (submitted: November 30, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2008)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Laura Dos, MDHospital Vall d'Hebron
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