title: Evaluation of synergistic effects of resynchronization therapy and a β-blocker up-titration strategy based on a predefined patient-management program: the RESTORE study.
abstract: Prior studies have suggested that a substantial number of eligible heart failure (HF) patients fail to receive β-blocker therapy, or receive it at a suboptimal dose. The aim of this study is to assess the benefit of a predefined management program designed for β-blocker up-titration, evaluating the synergistic effect of cardiac resynchronization therapy (CRT) and β-blockers in a HF population. The Resynchronization Therapy and β-Blocker Titration (RESTORE) study is a prospective, case-control, multicenter cohort study designed to test the hypothesis that a β-blocker up-titration strategy based on a predefined management program maximizes the beneficial effect of CRT, increasing the number of patients reaching the target dose of β-blockers and improving their clinical outcome. All study patients receive an implantable defibrillator for CRT delivery in accordance with current guidelines. Enrollments started in December 2011 and are scheduled to end in December 2014. Approximately 250 consecutive patients will be prospectively enrolled in 6 Italian centers and followed up for 24 months after implantation. The primary endpoint is to demonstrate that CRT may allow titration of β-blockers until the optimal dose, or at least to the effective dose, in patients with HF. This study might provide important information about the benefit of a predefined management program for β-blocker up-titration in patients receiving CRT. Moreover, assessment of health-care utilization and the consumption of resources will allow estimating the potential utility of remote monitoring by means of an automated telemedicine system in facilitating the titration of β-blockers in comparison with a standard in-hospital approach.
authors.affiliation: Cardiology Unit, "Card. G. Panico" Hospital, Tricase, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Palmisano
authors.forename: Ernesto
authors.initials: E
authors.lastname: Ammendola
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Onofrio
authors.forename: Michele
authors.initials: M
authors.lastname: Accogli
authors.forename: Leonardo
authors.initials: L
authors.lastname: Calò
authors.forename: Antonio
authors.initials: A
authors.lastname: Ruocco
authors.forename: Antonio
authors.initials: A
authors.lastname: Rapacciuolo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Del Giorno
authors.forename: Valter
authors.initials: V
authors.lastname: Bianchi
authors.forename: Maurizio
authors.initials: M
authors.lastname: Malacrida
authors.forename: Sergio
authors.initials: S
authors.lastname: Valsecchi
authors.forename: Edoardo
authors.initials: E
authors.lastname: Gronda
mesh_terms: D058671:Adrenergic beta-1 Receptor Antagonists / Q000008:administration & dosage*; D017298:Bisoprolol / Q000008:administration & dosage*; D002227:Carbazoles / Q000008:administration & dosage*; D058406:Cardiac Resynchronization Therapy / Q000379:methods*; D000077261:Carvedilol; D016022:Case-Control Studies; D003131:Combined Modality Therapy / Q000379:methods; D017147:Defibrillators, Implantable; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D011412:Propanolamines / Q000008:administration & dosage*; D011446:Prospective Studies; D012107:Research Design; D017186:Titrimetry / Q000379:methods*
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D017298:Bisoprolol