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RECRUITINGINTERVENTIONAL

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

Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥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 ...) - Providing willing to sign a consent form - Affiliated to a French Health Insurance system. Who Should NOT Join This Trial: - 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 - History of syncope in the previous 6 months - Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy) - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * ≥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 ...) * Providing informed consent * Affiliated to a French Health Insurance system. Exclusion Criteria: * 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 * History of syncope in the previous 6 months * Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy) * 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)

Treatments Being Tested

DEVICE

ICD implantation

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.

DEVICE

No ICD implantation

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.

Locations (19)

Centre Hospitalier d'Aix en provence
Aix-en-Provence, France
CHU Amiens-Picardie-Site sud
Amiens, France
CHU Brest - Hôpital La Cavale Blanche
Brest, France
HôpitalHenri Mondor
Créteil, France
CHU Grenoble Alpes
La Tronche, France
Groupement d'Hôpitaux de l'Institut Catholique de Lille
Lomme, France
Hôpital de La Timone
Marseille, France
Hôpital de Brabois
Nancy, France
CHU de Nantes
Nantes, France
Hôpital européen Georges Pompidou
Paris, France
Hôpital Pitié-Salpétrière
Paris, France
Hôpital Bichat - Claude Bernard
Paris, France
CHU Poitiers
Poitiers, France
Hôpital Pontchaillou
Rennes, France
CHU de Rouen
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France
CHU Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, France
Hôpital Trousseau
Tours, France