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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01482598
First received: November 28, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Congestive Heart Failure Treated
Device: Remote Care Follow up
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: COR HF - Clinical Benefits in Optimized Remote HF Patient Management

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Combined Endpoint on patient clinical outcome [ Time Frame: 12 months follow up ] [ Designated as safety issue: Yes ]

    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:
  • Efficacy and safety of CRT in remote care pts [ Time Frame: 12 and 24 months follow up ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 438
Study Start Date: October 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, Merlin.net
No Intervention: Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482598

Locations
Italy
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
MultiMedica IRCCS
Milano, Italy
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Napoli, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy
Ospedale S. Chiara - Cisanello
Pisa, Italy
Policlinico Tor Vergata
Roma, Italy
Ospedale Vannini
Roma, Italy
Ospedale S.M. della Misericordia
Udine, Italy
Ospedale di Belcolle
Viterbo, Italy
Sponsors and Collaborators
St. Jude Medical
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 Policlinico Tor Vergata, Roma
Principal Investigator: Alessandro Capucci, Prof. Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona
Principal Investigator: Francesco Solimene, MD Casa di Cura "Montevergine", Mercogliano (AV)
  More Information

Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01482598     History of Changes
Other Study ID Numbers: CR‐11‐017‐IT‐HF
Study First Received: November 28, 2011
Last Updated: July 17, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by St. Jude Medical:
Heart Failure
Cardiac Resynchronization Therapy
Remote Care
Disease Management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014