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

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. Identifier: NCT01482598
Recruitment Status : Unknown
Verified March 2016 by Abbott Medical Devices.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2011
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Treated Device: Remote Care Follow up Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: COR HF - Clinical Benefits in Optimized Remote HF Patient Management
Study Start Date : October 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: Home monitoring, Remote monitoring,

No Intervention: Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.

Primary Outcome Measures :
  1. 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, AT/AF episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
    • proportion of patients with inappropriate ICD therapies delivered at 12 months

Secondary Outcome Measures :
  1. Efficacy and safety of CRT in remote care pts [ Time Frame: 12 and 24 months follow up ]

    Proportion of patients with additional unscheduled clinic fups at 24 months

    • % biventricular pacing at 12 and 24 months
    • LVESV reduction >15% at 12 months
    • Time to first clinical event
    • Time from onset of the event to the clinical intervention
    • Mortality at 24 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01482598

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


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Responsible Party: Abbott Medical Devices Identifier: NCT01482598     History of Changes
Other Study ID Numbers: CR‐11‐017‐IT‐HF
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Abbott Medical Devices:
Heart Failure
Cardiac Resynchronization Therapy
Remote Care
Disease Management
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases