Clinical Benefits in Optimized Remote HF Patient Management (COR-HF)

October 22, 2020 updated by: Abbott Medical Devices

COR HF - Clinical Benefits in Optimized Remote HF Patient Management

The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The outcome measure of the study is a combined endpoint of:

  • Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
  • Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria "Ospedali Riuniti"
      • Bari, Italy
        • Policlinico Consorziale
      • Brescia, Italy
        • Spedali Civili
      • Catania, Italy
        • Ospedale Ferrarotto Vittorio Emanuele
      • Como, Italy
        • Ospedale S. Anna
      • Firenze, Italy
        • Azienda Ospedaliero Universitaria Careggi
      • Napoli, Italy
        • Azienda ospedaliera dei Colli - Ospedale Monaldi
      • Piacenza, Italy
        • Ospedale Guglielmo da Saliceto
      • Pisa, Italy
        • Ospedale S. Chiara - Cisanello
      • Roma, Italy
        • Policlinico Tor Vergata
      • Roma, Italy
        • Ospedale Vannini
      • Viterbo, Italy
        • Ospedale di Belcolle
    • Avellino
      • Mercogliano, Avellino, Italy
        • Casa di Cura "Montevergine"
    • Padova
      • Camposampiero, Padova, Italy
        • Ospedale Pietro Cosma
    • Palermo
      • Cefalù, Palermo, Italy
        • Osp. S.Raffaele Giglio
    • Torino
      • Ciriè, Torino, Italy
        • Presidio Ospedaliero Riunito di Ciriè
    • Treviso
      • Conegliano, Treviso, Italy
        • Presidio Ospedaliero di Conegliano
    • Verona
      • Peschiera del Garda, Verona, Italy
        • Casa di Cura Pederzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
  • 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
  • Left Bundle Branch Block (LBBB)
  • Patients must be able to provide written informed consent
  • Patients are mentally capable to participate in the Investigation (based on physician's discretion)

Exclusion Criteria:

  • Patients already implanted with CRT or CRT-D device to be replaced
  • Patients in long-standing persistent or permanent AT/AF
  • Patients in dialysis treatment at the time of enrollment
  • Patients in parenteral inotropic therapy at the time of enrollment
  • Patients with epicardial Left Ventricular (LV) lead
  • Patients with mechanical valvular prosthesis
  • Patients with life expectancy < 12 months
  • Patients actively considered for cardiac transplant
  • Patients < 18 years old
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Optimal Remote Care
Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant.
Device: Remote Care Follow up
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
Other Names:
  • Home monitoring, Remote monitoring, Merlin.net
No Intervention: Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined Endpoint on Patient Clinical Outcome
Time Frame: 12 months follow up

Combined Endpoint:

  • proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
  • proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Luigi Padeletti, Prof., Azienda Ospedaliero-Universitaria Careggi, Firenze
  • Principal Investigator: Maria Grazia Bongiorni, MD, Ospedale S.Chiara-Cisanello, Pisa
  • Principal Investigator: Gerardo Ansalone, MD, Ospedale Vannini, Roma
  • Principal Investigator: Gianluca Botto, MD, Ospedale S. Anna, Como
  • Principal Investigator: Antonio Curnis, MD, Spedali Civili, Brescia
  • Principal Investigator: Stefano Favale, Prof., Policlinico Consorziale, Bari
  • Principal Investigator: Edoardo Gronda, MD, Multimedica IRCCS, Milano
  • Principal Investigator: Roberto Verlato, MD, Ospedale Pietro Cosma, Camposampiero (PD)
  • Principal Investigator: Alessandro Proclemer, MD, Ospedale S.M. della Misericordia, Udine
  • Principal Investigator: Luca Santini, MD, University of Rome Tor Vergata
  • Principal Investigator: Alessandro Capucci, Prof., Azienda Ospedaliero, Universitaria Ospedali Riuniti
  • Principal Investigator: Francesco Solimene, MD, Casa di Cura "Montevergine", Mercogliano (AV)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-11-017-IT-HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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