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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723865
First Posted: November 8, 2012
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Effect Group, Italy
  Purpose

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).


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.

Resource links provided by NLM:


Further study details as provided by Effect Group, Italy:

Primary Outcome Measures:
  • unplanned hospitalizations or death [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures:
  • All reasons hospitalizations [ Time Frame: 1 year ]
  • Hospitalization for cardiac causes [ Time Frame: 1 year ]
  • Myocardial infarction [ Time Frame: 1 year ]
    Incidence of myocardial infarction

  • Ventricular tachycardia or fibrillation [ Time Frame: 1 year ]
    Incidence of ventricular tachycardia or fibrillation

  • Atrial fibrillation [ Time Frame: 1 year ]
    Incidence of atrial fibrillation episodes.

  • Heart transplantation [ Time Frame: 1 year ]
    heart transplantation occurence

  • Cost for National Health System (NHS) [ Time Frame: 1 year ]
    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.

  • Clinical benefit [ Time Frame: 1 year ]
    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).


Other Outcome Measures:
  • Autonomic activity [ Time Frame: 1 year ]
    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.


Enrollment: 988
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723865


Locations
Italy
Ospedali riuniti di Ancona
Ancona, Italy, 60126
Azienda Ospededaliero Universitaria Policlinico
Bari, Italy, 70125
Ospedale di Venere
Bari, Italy, 70131
Ospedale S.Spirito
Casale MOnferrato, Italy, 15033
Ferrari Hospital
Casarano, Italy, 73042
Presidio Ospedaliero Ferrari
Castrovillari, Italy, 87012
Policlinico V,Emanuele - Cardiologia Ferrarotto
Catania, Italy, 95124
Fondazione Istituto San Raffaele G.Giglio
Cefalù, Italy, 90015
Dep. of Cardiology, Civic Hospital
Ciriè, Italy, 10073
Vito Fazzi Hospital
Lecce, Italy, 73100
Civic Hospital
Moncalieri, Italy, 10024
Ospedale dei Colli - Monaldi
Napoli, Italy, 80100
Clinica Mediterranea
Napoli, Italy, 80122
Ospedale dei Colli, Monaldi
Napoli, Italy, 80131
Dept. Cardiology, S. Cuore Hospital
Negrar, Italy, 37024
Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
Padova, Italy, 35128
Sponsors and Collaborators
Effect Group, Italy
Investigators
Principal Investigator: Gianfranco Buja, MD University of Padua
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Effect Group, Italy
ClinicalTrials.gov Identifier: NCT01723865     History of Changes
Other Study ID Numbers: Effect
First Submitted: October 23, 2012
First Posted: November 8, 2012
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Effect Group, Italy:
Heart failure
Remote Monitoring
ICD
Follow-up

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases