Clinical trial NCT00703352: Eplerenone in Systemic Right Ventricle
Official title: Aldosterone Antagonists in Systemic Right Ventricle: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transposition of Great Vessels
Atrial Switch Procedure
Keywords: Transposition of the great arteries.
Transposition of the great vessels.
Mustard.
Senning.
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-06-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Right ventricular mass assessed by cardiac-magnetic resonance
timeFrame: 1 year
Secondary outcomes:
measure: Right ventricular ejection fraction and myocardial fibrosis mass, assessed by cardiac magnetic resonance
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Laura Dos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dos L, Pujadas S, Estruch M, Mas A, Ferreira-Gonzalez I, Pijuan A, Serra R, Ordonez-Llanos J, Subirana M, Pons-Llado G, Marsal JR, Garcia-Dorado D, Casaldaliga 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.