Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy (ReCONSIDER)
Sudden Cardiac Death Due to Cardiac Arrhythmia, Dilated Cardiomyopathy
About this trial
This is an interventional prevention trial for Sudden Cardiac Death Due to Cardiac Arrhythmia focused on measuring Nonischemic dilated cardiomyopathy, Sudden cardiac death risk stratification, Tiered two-step approach, Noninvasive risk factors, Cardiac magnetic resonance imaging, Programmed ventricular stimulation
Eligibility Criteria
Inclusion Criteria:
ALL of the following criteria must be fulfilled:
- Dilated cardiomyopathy diagnosis based on the ESC proposed criteria1: Dilation based on left ventricular end-diastolic diameter or volume >2SD larger than age, gender, and body surface area adjusted normal values, hypokinesia based on left ventricular ejection fraction ≤50%, not attributable to loading conditions or coronary artery disease. In cases of LVEF<45%, otherwise unexplained, and no evident ventricular dilation, the diagnosis of hypokinetic, nondilated CMP will be made
- Patients will have to have been diagnosed >6 months prior to enrolment in order to exclude reversible myocarditis cases
- Be on sinus rhythm or with paroxysmal atrial fibrillation to facilitate noninvasive risk factor (NIRF) presence assessment
- Age >18 years and <80 years
- On optimal medical therapy for at least 3 months
Exclusion Criteria:
A patient will be excluded from the study if any of the following criteria are present:
- Significant ventricular extrasystole burden (>10,000/24hrs or >10% PVCs) on 24hr ambulatory ECG (PVC-induced cardiomyopathy)38, 39, persisting even after all pharmacologic and/or interventional (ablation) attempts
- Permanent atrial fibrillation
- More than moderate left-sided valvular heart disease
- Epicardial vessel lumen stenoses >70% detected on coronary angiogram36 in a major coronary artery
- Expected survival <12months
- Pregnancy (planned and accidental)
- Stage IIIb chronic kidney disease (estimated glomerular filtration rate <30ml/hr). This mainly relates to the non-tachycardic SCD mechanisms in this population (bradycardia/pulseless electrical activity)40-42, not amenable to antitachycardic ICD interventions
- NYHA IV functional class
- Participation in another study with an active treatment arm
- Contraindication to either MRI performance or insertion of a transvenous ICD system
Sites / Locations
- Hippokrateion General Hospital of AthensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
No Intervention
No Intervention
Active Comparator
Sham Comparator
Sham Comparator
Sham Comparator
LVEF between 35%-50%, no noninvasive risk factors (NIRFs)
LVEF between 35%-50%, NIRFs present, noninducible
LVEF between 35%-50%, NIRFs present, inducible
LVEF <35%, no NIRFs present, noninducible
LVEF <35%, NIRFs present, noninducible
LVEF <35%, NIRFs present, inducible
Follow up, no further intervention
Follow up, no further intervention
All patients in this group will receive an ICD
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%