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

Assistance Publique - Hôpitaux de Paris730 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

730

Conditions

Interventions

ICD implantationDEVICE

This 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 implantationDEVICE

Patients 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.

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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)

Locations (19)

Centre Hospitalier d'Aix en provence

Aix-en-Provence, France

RECRUITING

CHU Amiens-Picardie-Site sud

Amiens, France

RECRUITING

HôpitalHenri Mondor

Créteil, France

RECRUITING

CHU Grenoble Alpes

La Tronche, France

RECRUITING

Groupement d'Hôpitaux de l'Institut Catholique de Lille

Lomme, France

RECRUITING

Hôpital de La Timone

Marseille, France

RECRUITING

Hôpital de Brabois

Nancy, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Hôpital Privé du Confluent

Nantes, France

RECRUITING

Hôpital européen Georges Pompidou

Paris, France

RECRUITING

...and 9 more locations

Outcomes

Primary Outcomes

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.