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

Heart Failure Clinical Trial

Official title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years: A Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Implantable Cardioverter Defibrillator
• Primary Prevention of Sudden Cardiac Death

• NCT number: NCT05373940
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alexandra BRUNEAU, Mrs
• Phone: +33144841712
• Email: alexandra.bruneau@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Completion date: May 31, 2030