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

Primary Purpose

Congestive Heart Failure Treated

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Remote Care Follow up
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure Treated focused on measuring Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casa di Cura "Montevergine"
  • Ospedale Pietro Cosma
  • Osp. S.Raffaele Giglio
  • Presidio Ospedaliero Riunito di Ciriè
  • Presidio Ospedaliero di Conegliano
  • Casa di Cura Pederzoli
  • Azienda Ospedaliero Universitaria "Ospedali Riuniti"
  • Policlinico Consorziale
  • Spedali Civili
  • Ospedale Ferrarotto Vittorio Emanuele
  • Ospedale S. Anna
  • Azienda Ospedaliero Universitaria Careggi
  • Azienda Ospedaliera dei Colli - Ospedale Monaldi
  • Ospedale Guglielmo da Saliceto
  • Ospedale S. Chiara - Cisanello
  • Ospedale Vannini
  • Policlinico Tor Vergata
  • Ospedale di Belcolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Optimal Remote Care

Optimal Standard Care

Arm Description

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.

Patient standard in clinic visits are performed every 6 months.

Outcomes

Primary Outcome Measures

Combined Endpoint on Patient Clinical Outcome
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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2011
Last Updated
October 22, 2020
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01482598
Brief Title
Clinical Benefits in Optimized Remote HF Patient Management
Acronym
COR-HF
Official Title
COR HF - Clinical Benefits in Optimized Remote HF Patient Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure Treated
Keywords
Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal Remote Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Optimal Standard Care
Arm Type
No Intervention
Arm Description
Patient standard in clinic visits are performed every 6 months.
Intervention Type
Device
Intervention Name(s)
Remote Care Follow up
Other Intervention Name(s)
Home monitoring, Remote monitoring, Merlin.net
Intervention Description
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
Primary Outcome Measure Information:
Title
Combined Endpoint on Patient Clinical Outcome
Description
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
Time Frame
12 months follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Padeletti, Prof.
Organizational Affiliation
Azienda Ospedaliero-Universitaria Careggi, Firenze
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Grazia Bongiorni, MD
Organizational Affiliation
Ospedale S.Chiara-Cisanello, Pisa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerardo Ansalone, MD
Organizational Affiliation
Ospedale Vannini, Roma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gianluca Botto, MD
Organizational Affiliation
Ospedale S. Anna, Como
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Curnis, MD
Organizational Affiliation
Spedali Civili, Brescia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefano Favale, Prof.
Organizational Affiliation
Policlinico Consorziale, Bari
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edoardo Gronda, MD
Organizational Affiliation
Multimedica IRCCS, Milano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Verlato, MD
Organizational Affiliation
Ospedale Pietro Cosma, Camposampiero (PD)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Proclemer, MD
Organizational Affiliation
Ospedale S.M. della Misericordia, Udine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luca Santini, MD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Capucci, Prof.
Organizational Affiliation
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Solimene, MD
Organizational Affiliation
Casa di Cura "Montevergine", Mercogliano (AV)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa di Cura "Montevergine"
City
Mercogliano
State/Province
Avellino
Country
Italy
Facility Name
Ospedale Pietro Cosma
City
Camposampiero
State/Province
Padova
Country
Italy
Facility Name
Osp. S.Raffaele Giglio
City
Cefalù
State/Province
Palermo
Country
Italy
Facility Name
Presidio Ospedaliero Riunito di Ciriè
City
Ciriè
State/Province
Torino
Country
Italy
Facility Name
Presidio Ospedaliero di Conegliano
City
Conegliano
State/Province
Treviso
Country
Italy
Facility Name
Casa di Cura Pederzoli
City
Peschiera del Garda
State/Province
Verona
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria "Ospedali Riuniti"
City
Ancona
Country
Italy
Facility Name
Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
Spedali Civili
City
Brescia
Country
Italy
Facility Name
Ospedale Ferrarotto Vittorio Emanuele
City
Catania
Country
Italy
Facility Name
Ospedale S. Anna
City
Como
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Azienda Ospedaliera dei Colli - Ospedale Monaldi
City
Napoli
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto
City
Piacenza
Country
Italy
Facility Name
Ospedale S. Chiara - Cisanello
City
Pisa
Country
Italy
Facility Name
Ospedale Vannini
City
Roma
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
Ospedale di Belcolle
City
Viterbo
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18975066
Citation
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.
Results Reference
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PubMed Identifier
18811805
Citation
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.
Results Reference
background
PubMed Identifier
21449992
Citation
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.
Results Reference
background
PubMed Identifier
20569704
Citation
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.
Results Reference
background
PubMed Identifier
21080835
Citation
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.
Results Reference
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Clinical Benefits in Optimized Remote HF Patient Management

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