Clinical Efficacy of Remote Monitoring in the Management of Heart Failure (EFFECT)
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|ClinicalTrials.gov Identifier: NCT01723865|
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : August 5, 2014
This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients with heart failure having an ICD-CRT implanted.
Study purpose The purpose of this study is to test the hypothesis that the monitoring of specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical course of patients with heart failure.
Study design This is a prospective observational study, comparing clinical course of patients with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring system (with or without weight and pressure external sensors) or followed by conventional ambulatory visits.
Primary endpoints The primary endpoint of this study is to document no superiority of unplanned hospital access for cardiac reasons (included access to the emergency units ) or death for cardiovascular causes in remote monitoring group (with or without weight and pressure external sensors) compared to conventional follow-up (usual care group).
|Condition or disease|
Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated remote monitoring system (RPM) in the management of patients with heart failure and implanted with ICDs and CRT-D.
The clinical benefit will be assessed by:
- Increased cardiovascular events (death, myocardial infarction, hospitalization).
- Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular tachycardia or ventricular fibrillation.
- Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life questionnaire.
The primary endpoint of this study is to estimate the incidence (and its accuracy) of the first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).
|Study Type :||Observational|
|Actual Enrollment :||988 participants|
|Observational Model:||Case Control|
|Official Title:||Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Patients with heart failure having an ICD-CRT implanted, followed by conventional visits.
Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring.
- unplanned hospitalizations or death [ Time Frame: 1 year ]unplanned hospitalization or for cardiac reasons or death for cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).
- All reasons hospitalizations [ Time Frame: 1 year ]
- Hospitalization for cardiac causes [ Time Frame: 1 year ]
- Myocardial infarction [ Time Frame: 1 year ]Incidence of myocardial infarction
- Ventricular tachycardia or fibrillation [ Time Frame: 1 year ]Incidence of ventricular tachycardia or fibrillation
- Atrial fibrillation [ Time Frame: 1 year ]Incidence of atrial fibrillation episodes.
- Heart transplantation [ Time Frame: 1 year ]heart transplantation occurence
- Cost for National Health System (NHS) [ Time Frame: 1 year ]Estimate the total cost for the NHS for the management of heart failure patients implanted with ICD-CRT, monitored or not with a remote monitoring system.
- Clinical benefit [ Time Frame: 1 year ]Evaluate the clinical benefit by means of 6-minute walking test, use of medications and changes of echocardiographic parameters, between the patients followed by conventional visits and patients followed by remote controls (with or without external sensors).
- Autonomic activity [ Time Frame: 1 year ]Indexes of autonomic activity such as th mean of standard deviations of RR intervals calculated on 5 minutes intervals (SDANN), activity log and "footprint", will be compared in patients followed by conventional visits of by remote controls.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723865
|Ospedali riuniti di Ancona|
|Ancona, Italy, 60126|
|Azienda Ospededaliero Universitaria Policlinico|
|Bari, Italy, 70125|
|Ospedale di Venere|
|Bari, Italy, 70131|
|Casale MOnferrato, Italy, 15033|
|Casarano, Italy, 73042|
|Presidio Ospedaliero Ferrari|
|Castrovillari, Italy, 87012|
|Policlinico V,Emanuele - Cardiologia Ferrarotto|
|Catania, Italy, 95124|
|Fondazione Istituto San Raffaele G.Giglio|
|Cefalù, Italy, 90015|
|Dep. of Cardiology, Civic Hospital|
|Ciriè, Italy, 10073|
|Vito Fazzi Hospital|
|Lecce, Italy, 73100|
|Moncalieri, Italy, 10024|
|Ospedale dei Colli - Monaldi|
|Napoli, Italy, 80100|
|Napoli, Italy, 80122|
|Ospedale dei Colli, Monaldi|
|Napoli, Italy, 80131|
|Dept. Cardiology, S. Cuore Hospital|
|Negrar, Italy, 37024|
|Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova|
|Padova, Italy, 35128|
|Principal Investigator:||Gianfranco Buja, MD||University of Padua|