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Published on: April 8, 2013
Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR
Joseph B Selvanayagam1,2,3, Trent Hartshorne1,2, Laurent Billot4
1Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia.
Insights
Sudden cardiac death risk in heart failure patients with mild-moderate dysfunction may be identified by cardiac magnetic resonance (CMR) fibrosis. A CMR-guided strategy for implantable cardioverter-defibrillator (ICD) insertion could improve survival.
Area of Science:
- Cardiology
- Medical Imaging
- Clinical Trials
Background:
- Sudden cardiac death (SCD) is common in heart failure patients with mild-moderate left ventricular (LV) systolic dysfunction (LVEF 36-50%).
- Current guidelines exclude these patients from primary prevention implantable cardioverter-defibrillator (ICD) therapy.
- Cardiac magnetic resonance (CMR) evidence of replacement fibrosis may identify patients at increased risk for SCD.
Purpose of the Study:
- To evaluate if a CMR-guided strategy for ICD insertion improves outcomes compared to standard care in patients with mild-moderate LV dysfunction and fibrosis.
- To determine if CMR-identified fibrosis can predict life-threatening ventricular arrhythmias.
Main Methods:
- The CMR GUIDE trial is a prospective, multicenter randomized controlled trial.
- Patients with mild-moderate LV dysfunction and CMR-confirmed fibrosis receive optimal heart failure therapy.
- Participants are randomized to primary prevention ICD or implantable loop recorder (ILR).
- Primary endpoint: time to SCD or hemodynamically significant ventricular arrhythmia (VF/VT) over 4-year follow-up.
Main Results:
- N/A - Results not yet available as this is a trial description.
Conclusions:
- The CMR GUIDE trial will clarify the role of myocardial fibrosis in predicting ventricular arrhythmias.
- A CMR-guided ICD strategy may significantly improve survival in this patient population.
- Positive results could lead to changes in international clinical guidelines for heart failure management.
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.
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