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Ann Noninvasive Electrocardiol. 2017 Jul;22(4). doi: 10.1111/anec.12420. Epub 2017 Jan 24.

Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR GUIDE): Study protocol for a randomized controlled trial.

Author information

1
Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia.
2
School of Medicine, Flinders University, Adelaide, SA, Australia.
3
Department of Heart Health, South Australian Health & Medical Research Institute, Adelaide, SA, Australia.
4
The George Institute, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
5
Royal Perth Hospital, Perth, WA, Australia.
6
Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany.
7
Faculty of Medicine, Monash University, Clayton, VIC, Australia.
8
Royal Brompton Hospital, London, England.

Abstract

BACKGROUND:

The majority of sudden cardiac death (SCD) in patients with heart failure occurs in those with mild-moderate left ventricular (LV) systolic dysfunction (LVEF 36-50%) who under current guidelines are ineligible for primary prevention implantable cardiac defibrillator (ICD) therapy. Recent data suggest that cardiac magnetic resonance (CMR) evidence of replacement fibrosis forms a substrate for malignant arrhythmia and therefore potentially identifies a subgroup at increased risk of SCD. Our hypothesis is that among patients with mild-moderate LV systolic dysfunction, a CMR-guided management strategy for ICD insertion based on the presence of scar or fibrosis is superior to a current strategy of standard care.

METHODS/DESIGN:

CMR GUIDE is a prospective, multicenter randomized control trial enrolling patients with mild-moderate LV systolic dysfunction and CMR evidence of fibrosis on optimal heart failure therapy. Participants will be randomized to receive either a primary prevention ICD or an implantable loop recorder (ILR). The primary endpoint is the time to SCD or hemodynamically significant ventricular arrhythmia (VF or VT) during an average 4-year follow-up. Secondary endpoints include quality of life assessed by Minnesota Living with Heart Failure Questionnaire, heart failure related hospitalizations, and a cost-utility analysis. Clinical trials.gov identifier NCT01918215.

DISCUSSION:

CMR GUIDE trial will add substantially to our understanding of the role of myocardial fibrosis and the risk of developing life-threatening ventricular arrhythmias. If the superiority of a CMR-guided approach over standard care is proven, it may change international clinical guidelines, with the potential to considerably increase survival in this growing patient population.

KEYWORDS:

cardiac magnetic resonance imaging; implantable cardiac defibrillator; left ventricular systolic dysfunction; sudden cardiac death; syncope

PMID:
28117536
DOI:
10.1111/anec.12420
[Indexed for MEDLINE]

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