Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
Study 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 ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
Eligibility
Primary outcome measure(s)
- Overall survival — 48 months after randomization
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.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier d'Aix en provence | Aix-en-Provence | France | Recruiting |
| CHU Amiens-Picardie-Site sud | Amiens | France | Recruiting |
| CHU Brest - Hôpital La Cavale Blanche | Brest | 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 européen Georges Pompidou | Paris | France | Recruiting |
| Hôpital Pitié-Salpétrière | Paris | France | Recruiting |
| Hôpital Bichat - Claude Bernard | Paris | France | Recruiting |
| CHU Poitiers | Poitiers | France | Recruiting |
| Hôpital Pontchaillou | Rennes | France | Recruiting |
| CHU de Rouen | Rouen | France | Recruiting |
| Centre Cardiologique du Nord | Saint-Denis | France | Recruiting |
| CHU Strasbourg | Strasbourg | France | Recruiting |
| Clinique Pasteur | Toulouse | France | Recruiting |
| Hôpital Trousseau | Tours | France | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05373940 on ClinicalTrials.gov ↗ ← All trials in France