The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
≥70 years old,
Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).
NYHA class II or III
Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)
Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)
Prior unstable sustained ventricular arrhythmia requiring external cardioversion
Myocardial infarction within the 40 days
Coronary artery intervention (catheter or surgical) within 90 days
Parallel
ICD implantation
DeviceThis group will undergo an ICD implantation (type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization. Patients of the "HFOT+ICD" group will be scheduled for ICD implantation.
No ICD implantation
DevicePatients of the "HFOT alone" group will not undergo ICD implantation (except if they develop sustained ventricular arrhythmias and fulfil for secondary prevention ICD implantation), and continue with medical therapy optimization only.
Overall survival
The primary endpoint will be the overall survival at 48 months after randomization to "HFOT alone" group or "HFOT+ICD" group. There is an annual follow-up with precise date of the fatal event and specific cause of death adjudicated by the blinded event committee.
Cardiovascular mortality
Rate of cardiovascular mortality assessed by a blinded endpoint committee.
Sudden cardiac death and death from ventricular arrhythmias
Rate of sudden cardiac death and rate of death from ventricular arrhythmias assessed by a blinded endpoint committee.
Unplanned hospitalization due to cardiovascular causes
Number of unplanned hospitalization due to cardiovascular causes
ICD related complications including inappropriate therapies
Number of ICD related therapies (antitachycardia pacing and shocks), hematoma, infection related to the device, lead dislodgement requiring intervention, pneumothorax and tamponade.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ministry of Health, France
Collaborator
