Assistance Publique - Hôpitaux de Paris
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.
Heart Failure
Primary Prevention of Sudden Cardiac Death
Implantable Cardioverter Defibrillator
ICD implantation
No ICD implantation
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 730 participants |
Masking: | Single |
Masking Description: | Three experts in cardiac electrophysiology and ICD will be in charge of uniformly approving, while blinded to the study group, ICD tracings, cardiovascular events, including specific causes of death, in order to validate the primary and secondary endpoints. |
Primary Purpose: | Prevention |
Official Title: | Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years: A Randomized Controlled Trial |
Actual Study Start Date : | June 29, 2022 |
Estimated Primary Completion Date : | May 31, 2030 |
Estimated Study Completion Date : | May 31, 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: Heart failure optimal therapy alone (HFOT) 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. |
Device: No ICD implantation |
Active Comparator: Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD) 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. |
Device: ICD implantation |
Ages Eligible for Study: | 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Centre Hospitalier d'Aix en provence
Aix-en-Provence, France, 13616
Recruiting
CHU Amiens-Picardie-Site sud
Amiens, France, 80054
Recruiting
HôpitalHenri Mondor
Créteil, France, 94000
Recruiting
CHU Grenoble Alpes
La Tronche, France, 38700
Recruiting
Groupement d'Hôpitaux de l'Institut Catholique de Lille
Lomme, France, 59462
Recruiting
Hôpital de La Timone
Marseille, France, 13385
Recruiting
Hôpital de Brabois
Nancy, France, 54710
Recruiting
CHU de Nantes
Nantes, France, 44093
Recruiting
Hôpital Privé du Confluent
Nantes, France, 44277
Recruiting
Hôpital européen Georges Pompidou
Paris, France, , 75015
Recruiting
Hôpital Pitié-Salpétrière
Paris, France, 75013
Recruiting
Hôpital Bichat - Claude Bernard
Paris, France, 75014
Recruiting
CHU Poitiers
Poitiers, France, 86021
Recruiting
Hôpital Pontchaillou
Rennes, France, 35033
Recruiting
CHU de Rouen
Rouen, France, 76000
Recruiting
Centre Cardiologique du Nord
Saint Denis, France, 93207
Recruiting
CHU Strasbourg
Strasbourg, France, 67200
Recruiting
Clinique Pasteur
Toulouse, France, 31076
Recruiting
Hôpital Trousseau
Tours, France, 37170