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

November 28, 2011
July 17, 2014
October 2011
August 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01482598 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Clinical Benefits in Optimized Remote HF Patient Management
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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Congestive Heart Failure Treated
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
  • 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.
    Intervention: Device: Remote Care Follow up
  • No Intervention: Optimal Standard Care
    Patient standard in clinic visits are performed every 6 months.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
438
August 2018
August 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01482598
CR‐11‐017‐IT‐HF
Yes
St. Jude Medical
St. Jude Medical
Not Provided
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)
St. Jude Medical
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP