Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR GUIDE): Study protocol for a randomized controlled trial.
Ann Noninvasive Electrocardiol
; 22(4)2017 Jul.
Article
em En
| MEDLINE
| ID: mdl-28117536
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Marca-Passo Artificial
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Desfibriladores Implantáveis
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Disfunção Ventricular Esquerda
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Imagem por Ressonância Magnética Intervencionista
Tipo de estudo:
Clinical_trials
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Guideline
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Qualitative_research
Limite:
Adult
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Female
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Humans
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Male
País como assunto:
Europa
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Oceania
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article