Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years (DILEMMA)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Primary Prevention of Sudden Cardiac Death; Heart Failure; Implantable Cardioverter Defibrillator

Treatments: Device: No ICD implantation; Device: ICD implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05373940

2021-A01959-32 (Other Identifier)

APHP200035

Details and patient eligibility

About

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.

Full 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 ≥ 70 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.

Enrollment: 730 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥70 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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730 participants in 2 patient groups

Heart failure optimal therapy alone (HFOT)

Experimental group

Description:

Heart failure Optimal therapy without implantable cardioverter defibrillator. This group will not undergo an ICD implantation. They will be treated according to the HFOT recommended in the latest guidelines.

Treatment:

Device: No ICD implantation

Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD)

Active Comparator group

Description:

Optimal medical therapy + implantable cardioverter defibrillator (HFOT+ICD). This group will undergo an ICD implantation (standard of care), any brand, CE marked, implantable (lifelong), available and reimbursed in the French market (the type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization.

Treatment:

Device: ICD implantation