Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT01723865
• Lead Sponsor: Effect Group, Italy

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-08
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 988

Inclusion Criteria

• Subjects >18 years
• patients implanted or eligible for implant with ICD-CRT-D, accordingly with guidelines of the centers, for heart failure treatment and/or primary prevention of sudden death

Exclusion Criteria

• Presence of clinically overt heart failure.
• Myocardial infarction within 2 months before enrolment.
• Significant concurrent illness or condition severely limiting life expectancy.
• Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
• History of drug or alcohol abuse within the last 2 years.
• Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
unplanned hospitalizations or death	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).

Secondary Outcome Measures

Name	Time	Method
All reasons hospitalizations	1 year
Hospitalization for cardiac causes	1 year
Myocardial infarction	1 year	Incidence of myocardial infarction
Atrial fibrillation	1 year	Incidence of atrial fibrillation episodes.
Heart transplantation	1 year	heart transplantation occurence
Cost for National Health System (NHS)	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.
Ventricular tachycardia or fibrillation	1 year	Incidence of ventricular tachycardia or fibrillation
Clinical benefit	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).

Trial Locations

Locations (16)

Ospedali riuniti di Ancona; 🇮🇹 Ancona, Italy

Azienda Ospededaliero Universitaria Policlinico; 🇮🇹 Bari, Italy

Ospedale di Venere; 🇮🇹 Bari, Italy

Ferrari Hospital; 🇮🇹 Casarano, Italy

Ospedale S.Spirito; 🇮🇹 Casale MOnferrato, Italy

Presidio Ospedaliero Ferrari; 🇮🇹 Castrovillari, Italy

Policlinico V,Emanuele - Cardiologia Ferrarotto; 🇮🇹 Catania, Italy

Fondazione Istituto San Raffaele G.Giglio; 🇮🇹 Cefalù, Italy

Dep. of Cardiology, Civic Hospital; 🇮🇹 Ciriè, Italy

Vito Fazzi Hospital; 🇮🇹 Lecce, Italy

Civic Hospital; 🇮🇹 Moncalieri, Italy

Ospedale dei Colli - Monaldi; 🇮🇹 Napoli, Italy

Clinica Mediterranea; 🇮🇹 Napoli, Italy

Ospedale dei Colli, Monaldi; 🇮🇹 Napoli, Italy

Dept. Cardiology, S. Cuore Hospital; 🇮🇹 Negrar, Italy

Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova; 🇮🇹 Padova, Italy