Clinical trial NCT01482598: Clinical Benefits in Optimized Remote HF Patient Management
Official title: COR HF - Clinical Benefits in Optimized Remote HF Patient Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure Treated
Keywords: Heart Failure
Cardiac Resynchronization Therapy
Remote Care
Disease Management
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Combined Endpoint on Patient Clinical Outcome
timeFrame: 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Mercogliano
country: Italy
facility: Casa di Cura "Montevergine"
state: Avellino
city: Camposampiero
country: Italy
facility: Ospedale Pietro Cosma
state: Padova
city: Cefalù
country: Italy
facility: Osp. S.Raffaele Giglio
state: Palermo
city: Ciriè
country: Italy
facility: Presidio Ospedaliero Riunito di Ciriè
state: Torino
city: Conegliano
country: Italy
facility: Presidio Ospedaliero di Conegliano
state: Treviso
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Pederzoli
state: Verona
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria "Ospedali Riuniti"
city: Bari
country: Italy
facility: Policlinico Consorziale
city: Brescia
country: Italy
facility: Spedali Civili
city: Catania
country: Italy
facility: Ospedale Ferrarotto Vittorio Emanuele
city: Como
country: Italy
facility: Ospedale S. Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli - Ospedale Monaldi
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Pisa
country: Italy
facility: Ospedale S. Chiara - Cisanello
city: Roma
country: Italy
facility: Ospedale Vannini
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Viterbo
country: Italy
facility: Ospedale di Belcolle
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Luigi Padeletti, Prof.
role: STUDY_CHAIR
affiliation: Ospedale S.Chiara-Cisanello, Pisa
name: Maria Grazia Bongiorni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Vannini, Roma
name: Gerardo Ansalone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale S. Anna, Como
name: Gianluca Botto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spedali Civili, Brescia
name: Antonio Curnis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Consorziale, Bari
name: Stefano Favale, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Multimedica IRCCS, Milano
name: Edoardo Gronda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Pietro Cosma, Camposampiero (PD)
name: Roberto Verlato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale S.M. della Misericordia, Udine
name: Alessandro Proclemer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rome Tor Vergata
name: Luca Santini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero, Universitaria Ospedali Riuniti
name: Alessandro Capucci, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa di Cura "Montevergine", Mercogliano (AV)
name: Francesco Solimene, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.