Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years (DILEMMA)

  • STATUS
    Recruiting
  • End date
    May 31, 2030
  • participants needed
    730
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 4 October 2022
medical therapy
ejection fraction
heart failure
sudden cardiac death

Summary

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 ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Description

Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.

Main objective 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 ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.

Details
Condition Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
Treatment ICD implantation, No ICD implantation
Clinical Study IdentifierNCT05373940
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥75 years old
Left ventricular ejection fraction ≤ 35%
NYHA class II or III
Heart failure HFOT ≥ 3 months
Providing informed consent
Affiliated to a French Health Insurance system

Exclusion Criteria

Enrolled in or planning to enroll in a conflicting interventional trial
Prior unstable sustained ventricular arrhythmia requiring external cardioversion
Myocardial infarction within the 40 days
Coronary artery intervention (catheter or surgical) within 90 days
History of syncope in the previous 6 months
Advanced cerebrovascular disease
Cognitive impairment leading to the incapacity of consent
Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year
Patient under tutorship, curatorship, or legal safeguard
Persons deprived of their liberty by judicial or administrative decision (prisoner)
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