Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

NCT ID: NCT01723865

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 988 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-03-31

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).

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Conventional

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

No interventions assigned to this group

Remote Monitoring

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Effect Group, Italy

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianfranco Buja, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

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

Cirié, , 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

Padua, , Italy

Countries

Italy

References

Capucci A, De Simone A, Luzi M, Calvi V, Stabile G, D'Onofrio A, Maffei S, Leoni L, Morani G, Sangiuolo R, Amellone C, Checchinato C, Ammendola E, Buja G. Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study. Europace. 2017 Sep 1;19(9):1493-1499. doi: 10.1093/europace/eux017.

Reference Type: DERIVED

PMID: 28407139 (View on PubMed)

De Simone A, Leoni L, Luzi M, Amellone C, Stabile G, La Rocca V, Capucci A, D'onofrio A, Ammendola E, Accardi F, Valsecchi S, Buja G. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study. Europace. 2015 Aug;17(8):1267-75. doi: 10.1093/europace/euu318. Epub 2015 Apr 4.

Reference Type: DERIVED

PMID: 25842271 (View on PubMed)

Other Identifiers

Effect

Identifier Type: -

Identifier Source: org_study_id