Clinical trial NCT01723865: Clinical Efficacy of Remote Monitoring in the Management of Heart Failure
Official title: Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Remote Monitoring
ICD
Follow-up
Lead sponsor: Effect Group, Italy
Sponsor class: NETWORK
First posted: 2012-11-08
Enrollment: 988
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both gender implanted or eligible for implant with ICD-CRT-D, for heart failure treatment and/or primary prevention of sudden death, followed or not by a remote monitoring system.

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).

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.

Primary outcomes:
measure: unplanned hospitalizations or death
timeFrame: 1 year
Secondary outcomes:
measure: All reasons hospitalizations
timeFrame: 1 year
measure: Hospitalization for cardiac causes
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Ventricular tachycardia or fibrillation
timeFrame: 1 year
measure: Atrial fibrillation
timeFrame: 1 year
measure: Heart transplantation
timeFrame: 1 year
measure: Cost for National Health System (NHS)
timeFrame: 1 year
measure: Clinical benefit
timeFrame: 1 year
Other outcomes:
measure: Autonomic activity
timeFrame: 1 year
Locations:
city: Ancona
country: Italy
facility: Ospedali riuniti di Ancona
city: Bari
country: Italy
facility: Azienda Ospededaliero Universitaria Policlinico
city: Bari
country: Italy
facility: Ospedale di Venere
city: Casale MOnferrato
country: Italy
facility: Ospedale S.Spirito
city: Casarano
country: Italy
facility: Ferrari Hospital
city: Castrovillari
country: Italy
facility: Presidio Ospedaliero Ferrari
city: Catania
country: Italy
facility: Policlinico V,Emanuele - Cardiologia Ferrarotto
city: Cefalù
country: Italy
facility: Fondazione Istituto San Raffaele G.Giglio
city: Ciriè
country: Italy
facility: Dep. of Cardiology, Civic Hospital
city: Lecce
country: Italy
facility: Vito Fazzi Hospital
city: Moncalieri
country: Italy
facility: Civic Hospital
city: Napoli
country: Italy
facility: Ospedale dei Colli - Monaldi
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Napoli
country: Italy
facility: Ospedale dei Colli, Monaldi
city: Negrar
country: Italy
facility: Dept. Cardiology, S. Cuore Hospital
city: Padova
country: Italy
facility: Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
Study officials:
affiliation: University of Padova
name: Gianfranco Buja, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.