Clinical Efficacy of Remote Monitoring in the Management of Heart Failure (EFFECT)

Effect Group, Italy

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01723865

Effect

Details and patient eligibility

About

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).

Full 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).

Enrollment: 988 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

988 participants in 2 patient groups

Conventional

Description:

Patients with heart failure having an ICD-CRT implanted, followed by conventional visits.

Remote Monitoring

Description:

Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring.