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Clinical Benefits in Optimized Remote HF Patient Management

NCT ID: NCT01482598

Last Updated: 2020-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

Conditions

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Congestive Heart Failure Treated

Keywords

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Heart Failure Cardiac Resynchronization Therapy Remote Care Disease Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Remote Care Follow up

Intervention Type DEVICE

Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed

Optimal Standard Care

Patient standard in clinic visits are performed every 6 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Home monitoring, Remote monitoring, Merlin.net

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Padeletti, Prof.

Role: STUDY_CHAIR

Azienda Ospedaliero-Universitaria Careggi

Maria Grazia Bongiorni, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale S.Chiara-Cisanello, Pisa

Gerardo Ansalone, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Vannini, Roma

Gianluca Botto, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale S. Anna, Como

Antonio Curnis, MD

Role: PRINCIPAL_INVESTIGATOR

Spedali Civili, Brescia

Stefano Favale, Prof.

Role: PRINCIPAL_INVESTIGATOR

Policlinico Consorziale, Bari

Edoardo Gronda, MD

Role: PRINCIPAL_INVESTIGATOR

Multimedica IRCCS, Milano

Roberto Verlato, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Pietro Cosma, Camposampiero (PD)

Alessandro Proclemer, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale S.M. della Misericordia, Udine

Luca Santini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Alessandro Capucci, Prof.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Francesco Solimene, MD

Role: PRINCIPAL_INVESTIGATOR

Casa di Cura "Montevergine", Mercogliano (AV)

Locations

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Casa di Cura "Montevergine"

Mercogliano, Avellino, Italy

Site Status

Ospedale Pietro Cosma

Camposampiero, Padova, Italy

Site Status

Osp. S.Raffaele Giglio

Cefalù, Palermo, Italy

Site Status

Presidio Ospedaliero Riunito di Ciriè

Cirié, Torino, Italy

Site Status

Presidio Ospedaliero di Conegliano

Conegliano, Treviso, Italy

Site Status

Casa di Cura Pederzoli

Peschiera del Garda, Verona, Italy

Site Status

Azienda Ospedaliero Universitaria "Ospedali Riuniti"

Ancona, , Italy

Site Status

Policlinico Consorziale

Bari, , Italy

Site Status

Spedali Civili

Brescia, , Italy

Site Status

Ospedale Ferrarotto Vittorio Emanuele

Catania, , Italy

Site Status

Ospedale S. Anna

Como, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, , Italy

Site Status

Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Site Status

Ospedale S. Chiara - Cisanello

Pisa, , Italy

Site Status

Ospedale Vannini

Roma, , Italy

Site Status

Policlinico Tor Vergata

Roma, , Italy

Site Status

Ospedale di Belcolle

Viterbo, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18975066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18811805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21449992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20569704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21080835 (View on PubMed)

Other Identifiers

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CR-11-017-IT-HF

Identifier Type: -

Identifier Source: org_study_id