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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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