title: Selection of potential predictors of worsening heart failure: rational and design of the SELENE HF study.
abstract: BACKGROUND
  Heart failure is a leading cause of hospitalization and a significant medical burden in our society. Implantable medical devices are nowadays established therapies in heart failure patients that not only provide cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICDs) therapy but are also able to continuously and remotely monitor diagnostic information of various physiologic parameters. The value of combining individual diagnostic variables to predict worsening of heart failure is still largely unclear but could eventually become a valuable tool towards a better heart failure management.
  
  
  METHODS
  SELENE HF (Selection of potential predictors of worsening Heart Failure) is an observational, multicentre study designed to prospectively collect follow-up and home monitoring data trends from a population of individuals with ICDs with or without resynchronization therapy (CRT-D), to document heart failure hospitalizations and deaths and to correlate these events with Home Monitoring data in order to identify the combination with the greatest sensitivity and specificity in predicting heart failure events.The purpose of this study is to describe the design of the study focusing on the Heart Failure Predicting model and statistical approach that will be used to analyse the data.
  
  
  CONCLUSIONS
  The results of the SELENE HF study could help to select and define potential predictors of worsening heart failure in patients with remotely monitored ICD or CRT-D devices.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT01836510.
authors.affiliation: aArrhythmology, A.O.U. Careggi, Firenze, Florence bCardiology Division, Sant'Anna Hospital, Como cElectrophysiology, Spedali Civili, Brescia dCardiology Division, Policlinico Casilino, Rome eUOSD Electrophysiology, Vincenzo Monaldi Hospital, Naples fCardiology Division, Multimedica Clinic, Milan gCardiology Division, San Filippo Neri Hospital, Rome hCardiology Division, Santa Croce Hospital, Cuneo iUOC Cardiology, Mater Salutis Hospital, Legnago, Verona jCardiology, University of Trieste, Trieste, Italy kBiotronik AG, Baar, Switzerland lBiotronik Italia, Milan, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Padeletti
authors.forename: Giovanni Luca
authors.initials: GL
authors.lastname: Botto
authors.forename: Antonio
authors.initials: A
authors.lastname: Curnis
authors.forename: Ermenegildo
authors.initials: E
authors.lastname: De Ruvo
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Onofrio
authors.forename: Edoardo
authors.initials: E
authors.lastname: Gronda
authors.forename: Renato Pietro
authors.initials: RP
authors.lastname: Ricci
authors.forename: Antonello
authors.initials: A
authors.lastname: Vado
authors.forename: Gabriele
authors.initials: G
authors.lastname: Zanotto
authors.forename: Massimo
authors.initials: M
authors.lastname: Zecchin
authors.forename: Xenia
authors.initials: X
authors.lastname: Antoniou
authors.forename: Alessio
authors.initials: A
authors.lastname: Gargaro
mesh_terms: D017147:Defibrillators, Implantable; D019468:Disease Management; D018450:Disease Progression; D006333:Heart Failure / Q000175:diagnosis* / Q000628:therapy*; D018575:Home Care Services, Hospital-Based; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D058998:Remote Sensing Technology / Q000379:methods; D012107:Research Design; D012307:Risk Factors; D018401:Sample Size