Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

Heart Failure Clinical Trial

— EFFECT  

Official title:

Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723865
• Other study ID #: Effect
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: August 4, 2014
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Effect Group, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 988
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	Ospedali riuniti di Ancona	Ancona
Italy	Azienda Ospededaliero Universitaria Policlinico	Bari
Italy	Ospedale di Venere	Bari
Italy	Ospedale S.Spirito	Casale MOnferrato
Italy	Ferrari Hospital	Casarano
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	Clinica Mediterranea	Napoli
Italy	Ospedale dei Colli - Monaldi	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

Sponsors (1)

Lead Sponsor	Collaborator
Effect Group, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Autonomic activity	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.	1 year	No
Primary	unplanned hospitalizations or death	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).	1 year	No
Secondary	All reasons hospitalizations		1 year	No
Secondary	Hospitalization for cardiac causes		1 year	No
Secondary	Myocardial infarction	Incidence of myocardial infarction	1 year	No
Secondary	Ventricular tachycardia or fibrillation	Incidence of ventricular tachycardia or fibrillation	1 year	No
Secondary	Atrial fibrillation	Incidence of atrial fibrillation episodes.	1 year	No
Secondary	Heart transplantation	heart transplantation occurence	1 year	No
Secondary	Cost for National Health System (NHS)	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.	1 year	No
Secondary	Clinical benefit	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).	1 year	No