title: Eplerenone in systemic right ventricle: double blind randomized clinical trial. The evedes study.
abstract: BACKGROUND
  There is no proven pharmacological strategy for the treatment of the failing systemic right ventricle (SRV) but myocardial fibrosis may play a role in its pathophysiology.
  
  
  METHODS
  We designed a double-blind, placebo-controlled clinical trial to assess the effects of eplerenone 50mg during 12 months on cardiac magnetic resonance parameters (SRV mass and ejection fraction) and neurohormonal and collagen turnover biomarker (CTB) levels.
  
  
  RESULTS
  Twenty six patients with atrial switch repair for transposition of the great arteries were randomized to eplerenone (n=14) or placebo (n=12) and 14 healthy volunteers served as controls for comparison of baseline neurohormones and CTB levels. The study population showed a good baseline profile in terms of SRV mass (57.4 ± 17 g/m(2)) and ejection fraction (54.9 ± 7.5%). However, levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), C terminal propeptide of type I procollagen (CICP) and C-terminal Telopeptide of type I Collagen (ICTP) were significantly elevated when compared to healthy controls. After one year of treatment, a trend toward reduction of CICP, N-terminal pro-Matrix Metalloproteinase 1 (NT-proMMP1), Tissue Inhibitor of Metalloproteinases 1 (TIMP1) and galectin 3 levels and a lower increase in ICTP in patients under eplerenone was observed. The reduction of SRV mass and the improvement of SRV function with eplerenone were not conclusive.
  
  
  CONCLUSIONS
  Patients with SRV treated with eplerenone showed an improvement of an altered baseline CTB profile suggesting that reduction of myocardial fibrosis might be a therapeutic target in these patients.
authors: Integrated Adult Congenital Heart Disease Unit of Vall d'Hebron University Hospital and Santa Creu i Sant Pau University Hospital, Barcelona, Spain; Autonomous University of Barcelona, Spain. Electronic address: ldos@vhebron.net.
authors: Laura
authors: L
authors: Dos
authors: Sandra
authors: S
authors: Pujadas
authors: Montserrat
authors: M
authors: Estruch
authors: Assumpta
authors: A
authors: Mas
authors: Ignacio
authors: I
authors: Ferreira-González
authors: Antònia
authors: A
authors: Pijuan
authors: Ricard
authors: R
authors: Serra
authors: Jordi
authors: J
authors: Ordóñez-Llanos
authors: Maite
authors: M
authors: Subirana
authors: Guillem
authors: G
authors: Pons-Lladó
authors: Josep R
authors: JR
authors: Marsal
authors: David
authors: D
authors: García-Dorado
authors: Jaume
authors: J
authors: Casaldàliga
mesh_terms: D000328:Adult; D000450:Aldosterone / Q000378:metabolism; D057791:Cardiac Imaging Techniques; D003094:Collagen / Q000378:metabolism; D004311:Double-Blind Method; D000077545:Eplerenone; D005260:Female; D005355:Fibrosis; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009206:Myocardium / Q000378:metabolism / Q000473:pathology; D013148:Spironolactone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D014188:Transposition of Great Vessels / Q000601:surgery; D016896:Treatment Outcome; D018497:Ventricular Dysfunction, Right / Q000188:drug therapy* / Q000473:pathology; D055815:Young Adult
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D000450:Aldosterone; D000077545:Eplerenone; D003094:Collagen
keywords: Aldosterone; Collagen turnover biomarkers; Heart failure; Transposition of the great vessels; Trials