Clinical trial NCT00885677: MOnitoring REsynchronization deviCes and cARdiac patiEnts
Official title: MOnitoring REsynchronization deviCes and cARdiac patiEnts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices

1. Remote monitoring with CareLink Network System
2. Standard management of the disease by means of scheduled routine in-patient follow-ups;

and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Detailed description: Major cardiovascular adverse events in patients with heart failure treated with cardiac resynchronization therapy (CRT-D) represent a big concern to the medical community, as they require hospitalizations and may lead to death.

Subjects with a history of heart failure are counseled regarding the importance of contacting their clinicians promptly if they experience any changes or worsening of their condition.

Acute heart failure episodes with hospitalizations represent one of the most relevant causes of health status deterioration for these patients. Moreover, atrial arrhythmias occurrence is a big issue, as it increases the risk of heart failure itself, stroke and inappropriate shocks. In addition to affecting patient health, hospital admission resulting from these complications will impact healthcare costs.

Latest generations of Medtronic CRT-D devices are equipped with a system that triggers an alarm if possible fluid accumulation is detected (OptiVol). This may initiate patient-clinician contact before evident cardiac decompensation. Moreover, advanced diagnostic capabilities for detecting atrial arrhythmias occurrence and total burden are available on such devices.

Importantly, all these devices are now able to inform physician of these events by remote monitoring with CareLink Network parameters, and have the potential of playing a key role in patient monitoring.

Over the last years, interest has been increasing in remote monitoring models for delivering care to HF patients, either as telemonitoring (transfer of physiological data through telephone or digital cable from home to healthcare provider) or as regular structured telephone contacts between patients and healthcare providers, which may or may not include data transfer.

Several studies with relatively large numbers of patients have been published (see table).

A recent meta-analysis found that remote monitoring programs for patients with chronic HF living in the community reduced admissions to hospital and all cause mortality by nearly one fifth while improving health related quality of life, but had no significant effect on all cause admission to hospital.

However, none of the published studies considered remote monitoring systems able to provide device-detected information on fluid accumulation, AT/AF total burden, arrhythmias occurrence and device-related issues in patients treated with CRT-D devices.

Early intervention may then be a key element in avoiding major cardiovascular events to occur and possible deterioration of the disease progression. The Carelink Network remote monitoring system, through Care Alerts, may initiate subject-clinician contact before typical signs and symptoms are exhibited, since it provides the physician with an automatic alert for atrial arrhythmias occurrence, fluid accumulation, and system integrity issues. However, clinical evidence must be provided of the superiority of this patient management strategy with respect to standard clinical practice, based on routine in-office visits.

Very recent findings showed that the use of CareLink in European clinical practice is technically feasible and that remote follow-up is an efficient method of surveillance of implanted patients. Moreover, the early detection and review of device and clinical events suggest the potential impact of remote monitoring on overall patient care.

There are a number of possible limitations with remote monitoring. The CareLink Network system requires that the patient establishes an initial contact between the device and the remote monitor unit, and that the unit is properly hooked up to the phone line. Not all patients may be able to perform the setup properly. There may be a delay by the physician in consulting patient data (for example over weekends), with a risk of adverse events occurring during that interval. There may be difficulties in contacting patients (e.g. if they are traveling). These possible limitations need to be properly assessed, especially for monitoring atrial arrhythmias, where the time factor is of importance for avoiding complications.

Remote patients' disease management has the potential for avoiding hospitalization. Clear demonstration that remote monitoring of AT/AF/HF plus strict treatment guidelines leads to a reduction in hospitalization rates has not been proven, and it could be a major argument for using this technology in routine clinical practice.

The MORE-CARE Study is aimed at comparing two different strategies of disease management in heart failure patients treated with CRT-D devices:

1. Remote disease management via Carelink Network system
2. Standard disease management by means of scheduled routine in-patient follow-ups. The main objective of the study is to demonstrate that the remote management strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Eligibility criteria: Inclusion Criteria:

* Patient indicated to CRT-ICD according to current guidelines:
* Left ventricular systolic dysfunction (LVEF≤35%),
* New York Heart Association functional class III-IV,
* QRS≥120 ms
* Optimized medical treatment.
* Patient implanted within the last 8 weeks with Medtronic CRT-ICD device equipped with fluid accumulation diagnostics, AT/AF monitoring capability, wireless telemetry for automatic remote data transmission and alerting system for physician.
* Patient with less than 8 weeks follow-up, who has not received Carelink® Network Monitor and was not managed by Cardiac Compass report reviewing.
* Carelink Network is available at patient's home
* Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties.
* Patient is willing and able to sign an informed consent form.

Exclusion Criteria:

* Inability to fully understand the instructions relating to remote monitoring using CareLink® Network.
* Permanent AT/AF.
* Patient had not been previously implanted with a CRT/CRT-D device.
* Patient has medical conditions that would limit study participation.
* Patient is less than 18 years of age.
* Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints.
* Patient meets any exclusion criteria required by local law.
* Inability or refusal to sign a patient informed consent form.
* Patient's life expectancy is less than one year in the opinion of the physician
* Patient is pregnant or breastfeeding.

Primary outcomes:
measure: Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.
timeFrame: 1 year since the randomization
measure: Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event
timeFrame: 2 years after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Institut Klinicke a Experimentalni Mediciny
city: Angers
country: France
facility: Centre Hospitalier Universitaire de Angers
city: Bordeaux
country: France
facility: Hôpital Cardiologique du Haut Lévêque
city: La Rochelle
country: France
facility: Centre Hospitalier
city: Lyon
country: France
facility: Hopital Louis Pradel
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Narbonne
country: France
facility: CHU
city: Orleans
country: France
facility: Hopital La Source
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
city: Paris
country: France
facility: Clinique Bizet
city: Saint Etienne
country: France
facility: Hopital du Nord
city: Tours
country: France
facility: CHRU
city: Athens
country: Greece
facility: Evaggelismos Hospital
city: Athens
country: Greece
facility: Henry Dynant Hospital - Athens
city: Heraklion
country: Greece
facility: University Hospital Herakleion
city: Marousi
country: Greece
facility: HYGEIA - Hospital
city: Thessaloniki
country: Greece
facility: University Hospital AHEPA Thessaloniki
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológia Intézet GOKI
city: Budapest
country: Hungary
facility: Semmelweis University AOK
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Chioggia
country: Italy
facility: Ospedale Civile
state: Venezia
city: Mirano
country: Italy
facility: Ospedale Civile
state: Venezia
city: Bari
country: Italy
facility: Policlinico Universitario
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Bologna
country: Italy
facility: Policlinico Universitario S. Orsola-Malpighi
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Catania
country: Italy
facility: Ospedale V.E. Ferrarotto
city: Catanzaro
country: Italy
facility: Ospedale Pugliese e Ciaccio
city: Catanzaro
country: Italy
facility: Sant'Anna Hospital
city: Lido di Camaiore (LU)
country: Italy
facility: Ospedale Unico della Versilia
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Napoli
country: Italy
facility: A.O. Monaldi
city: Negrar
country: Italy
facility: Azienda Ospedaliera Sacro Cuore Don Calabria
city: Ostia
country: Italy
facility: Ospedale Giovan Battista Grassi
city: Paderno Dugnano
country: Italy
facility: Clinica San Carlo
city: Palermo
country: Italy
facility: Ospedali Civico e Benfratelli
city: Pesaro
country: Italy
facility: Ospedale San Salvatore
city: Pisa
country: Italy
facility: Istituto di Fisiologia Clinica - CNR
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Roma
country: Italy
facility: Azienda Complesso Ospedaliero San Filippo Neri
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Rovereto
country: Italy
facility: Ospedale Santa Maria Del Carmine
city: Trento
country: Italy
facility: P.O. di Trento P.O.S.Chiara
city: Trieste
country: Italy
facility: Azienda Ospedaliera-Ospedali Riuniti
city: Varese
country: Italy
facility: Ospedale E. Macchi
city: Verona
country: Italy
facility: Ospedale Civile Maggiore di Borgo Trento
city: Den Haag
country: Netherlands
facility: MC Haaglanden - Locatie Westeinde
city: Bratislava
country: Slovakia
facility: NUSCH
city: Kosice
country: Slovakia
facility: VUSCH
city: Alicante
country: Spain
facility: Hospital De Torrevieja
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Valencia
country: Spain
facility: Hospital Universitario La Fé
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Basel
country: Switzerland
facility: Universitätsspital
city: Geneva
country: Switzerland
facility: University Hospital
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: University Hospitals of Geneva Switzerland
name: Haran Burri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Universitario Sant'Orsola, Bologna, Italy
name: Giuseppe Boriani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera San Filippo Neri, Roma, Italy
name: Renato Pietro Ricci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Valencia, Spain
name: Aurelio Quesada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Universitario di Bari, Italy
name: Stefano Favale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IKEM, Prague, Czech Republic
name: Josef Kautzner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital du Nord, Saint Etienne, France
name: Antoine Da Costa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burri H, Quesada A, Ricci RP, Boriani G, Davinelli M, Favale S, Da Costa A, Kautzner J, Moser R, Navarro X, Santini M. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Am Heart J. 2010 Jul;160(1):42-8. doi: 10.1016/j.ahj.2010.04.005.
citation: Boriani G, Da Costa A, Ricci RP, Quesada A, Favale S, Iacopino S, Romeo F, Risi A, Mangoni di S Stefano L, Navarro X, Biffi M, Santini M, Burri H; MORE-CARE Investigators. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring. J Med Internet Res. 2013 Aug 21;15(8):e167. doi: 10.2196/jmir.2608.
citation: Burri H, da Costa A, Quesada A, Ricci RP, Favale S, Clementy N, Boscolo G, Villalobos FS, Mangoni di S Stefano L, Sharma V, Boriani G; MORE-CARE Investigators. Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator. Europace. 2018 May 1;20(5):e69-e77. doi: 10.1093/europace/eux206.
citation: Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S Stefano L, Burri H; MORE-CARE Study Investigators. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2017 Mar;19(3):416-425. doi: 10.1002/ejhf.626. Epub 2016 Aug 28.