Clinical Benefits in Optimized Remote HF Patient Management

Overview

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.

Full Title of Study: “COR HF – Clinical Benefits in Optimized Remote HF Patient Management”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

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

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

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

References

Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes. J Interv Card Electrophysiol. 2009 Jan;24(1):53-61. doi: 10.1007/s10840-008-9321-3. Epub 2008 Oct 31.

Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation–ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.

Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Hettrick DA; FAST Study Investigators. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. 2011 Mar-Apr;17(2):51-5. doi: 10.1111/j.1751-7133.2011.00220.x. Epub 2011 Mar 21.

Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034.

Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. Erratum In: N Engl J Med. 2011 Feb 3;364(5):490. N Engl J Med. 2013 Nov 7;369(19):1869.

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