Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

NCT01723865 | Completed

• 1 other identifier: Effect
• Study Type: observational
• Target: 988
• Locations: 1 country
• Sites: 16

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).

Conditions

Heart Failure

Keywords

Heart failure; Remote Monitoring; ICD; Follow-up

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• All reasons hospitalizations

  1 year

• Hospitalization for cardiac causes

  1 year

• Myocardial infarction

  1 year

• Ventricular tachycardia or fibrillation

  1 year

• Atrial fibrillation

  1 year

Other Outcomes (1)

• Autonomic activity

  1 year

Study Arms (2)

Conventional

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

Remote Monitoring

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Effect Group, Italy: lead

Study Sites (16)

Ospedali riuniti di Ancona

Ancona, 60126, Italy

Location

Azienda Ospededaliero Universitaria Policlinico

Bari, 70125, Italy

Location

Ospedale di Venere

Bari, 70131, Italy

Location

Ospedale S.Spirito

Casale Monferrato, 15033, Italy

Location

Ferrari Hospital

Casarano, 73042, Italy

Location

Presidio Ospedaliero Ferrari

Castrovillari, 87012, Italy

Location

Policlinico V,Emanuele - Cardiologia Ferrarotto

Catania, 95124, Italy

Location

Fondazione Istituto San Raffaele G.Giglio

Cefalù, 90015, Italy

Location

Dep. of Cardiology, Civic Hospital

Cirié, 10073, Italy

Location

Vito Fazzi Hospital

Lecce, 73100, Italy

Location

Civic Hospital

Moncalieri, 10024, Italy

Location

Ospedale dei Colli - Monaldi

Napoli, 80100, Italy

Location

Clinica Mediterranea

Napoli, 80122, Italy

Location

Ospedale dei Colli, Monaldi

Napoli, 80131, Italy

Location

Dept. Cardiology, S. Cuore Hospital

Negrar, 37024, Italy

Location

Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova

Padua, 35128, Italy

Location

Related Publications (2)

• 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.

  PMID: 28407139 DERIVED

• 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.

  PMID: 25842271 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gianfranco Buja, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: November 8, 2012
• Study Start: May 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

IT (16)