TY - JOUR AU - Krum H. AU - Hillis G. AU - Selvanayagam J. AU - Hartshorne T. AU - Grover S. AU - Jung W. AU - Prasad S. AU - McGavigan A. AU - Billot Laurent AB -

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.

AD - Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia.
School of Medicine, Flinders University, Adelaide, SA, Australia.
Department of Heart Health, South Australian Health & Medical Research Institute, Adelaide, SA, Australia.
The George Institute, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Royal Perth Hospital, Perth, WA, Australia.
Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany.
Faculty of Medicine, Monash University, Clayton, VIC, Australia.
Royal Brompton Hospital, London, England. AN - 28117536 BT - Ann Noninvasive ElectrocardiolAnnals of Noninvasive Electrocardiology DP - NLM ET - 2017/01/25 J2 - Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc LA - eng LB - AUS
OCS
CV
FY17 N1 - Selvanayagam, Joseph B
Hartshorne, Trent
Billot, Laurent
Grover, Suchi
Hillis, Graham S
Jung, Werner
Krum, Henry
Prasad, Sanjay
McGavigan, Andrew D
United States
Ann Noninvasive Electrocardiol. 2017 Jan 24. doi: 10.1111/anec.12420. N2 -

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.

PY - 2017 SN - 1542-474X (Electronic)
1082-720X (Linking) ST - Ann. Noninvasive Electrocardiol. T2 - Ann Noninvasive ElectrocardiolAnnals of Noninvasive Electrocardiology TI - Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR GUIDE): Study protocol for a randomized controlled trial Y2 - FY17 ER -