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Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalised follow-up procedures

Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalised follow-up procedures
Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalised follow-up procedures
Aims: we wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices.

Methods: REM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted lifeyear, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study.

Conclusion: REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach
1388-9842
1039-1045
Morgan, John M.
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Dimitrov, Borislav D
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Gill, Jas
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Kitt, Sue
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Ng, G Andre
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McComb, Janet M.
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Raftery, James
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Roderick, Paul
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Seed, Alison
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Williams, Simon G.
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Witte, Klaus K.
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Wright, D. Jay
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Yao, Guiqing Lily
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Cowie, Martin R.
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Morgan, John M.
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Dimitrov, Borislav D
366d715f-ffd9-45a1-8415-65de5488472f
Gill, Jas
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Kitt, Sue
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Ng, G Andre
a83963c6-f717-4b4e-9187-6cd23c794373
McComb, Janet M.
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Raftery, James
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Roderick, Paul
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Seed, Alison
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Williams, Simon G.
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Witte, Klaus K.
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Wright, D. Jay
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Yao, Guiqing Lily
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Cowie, Martin R.
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Morgan, John M., Dimitrov, Borislav D, Gill, Jas, Kitt, Sue, Ng, G Andre, McComb, Janet M., Raftery, James, Roderick, Paul, Seed, Alison, Williams, Simon G., Witte, Klaus K., Wright, D. Jay, Yao, Guiqing Lily and Cowie, Martin R. (2014) Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalised follow-up procedures. European Journal of Heart Failure, 16 (9), 1039-1045. (doi:10.1002/ejhf.149). (PMID:25136791)

Record type: Article

Abstract

Aims: we wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices.

Methods: REM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted lifeyear, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study.

Conclusion: REM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach

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Submitted date: 18 August 2014
e-pub ahead of print date: 18 August 2014
Published date: September 2014
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 367476
URI: https://eprints.soton.ac.uk/id/eprint/367476
ISSN: 1388-9842
PURE UUID: 3c8c8477-a8bf-49ad-ad52-6826db5b836d
ORCID for Paul Roderick: ORCID iD orcid.org/0000-0001-9475-6850

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Date deposited: 29 Aug 2014 11:30
Last modified: 24 Sep 2019 00:56

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Contributors

Author: John M. Morgan
Author: Borislav D Dimitrov
Author: Jas Gill
Author: Sue Kitt
Author: G Andre Ng
Author: Janet M. McComb
Author: James Raftery
Author: Paul Roderick ORCID iD
Author: Alison Seed
Author: Simon G. Williams
Author: Klaus K. Witte
Author: D. Jay Wright
Author: Martin R. Cowie

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