Luigi Padeletti1, Giovanni Luca Botto, Antonio Curnis, Ermenegildo De Ruvo, Antonio D'Onofrio, Edoardo Gronda, Renato Pietro Ricci, Antonello Vado, Gabriele Zanotto, Massimo Zecchin, Xenia Antoniou, Alessio Gargaro. 1. 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.
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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01836510.
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 failurepatients 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01836510.
Authors: Enrico Bertagnin; Antonio Greco; Giuseppe Bottaro; Paolo Zappulla; Imma Romanazzi; Maria Daniela Russo; Marco Lo Presti; Noemi Valenti; Giuseppe Sollano; Valeria Calvi Journal: Int J Cardiol Heart Vasc Date: 2021-01-28