Ireland
--:--IST
Recruiting Not applicable

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

NCT05373940 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-06-29
Last updated
2026-03-24

Condition(s) studied

Heart FailurePrimary Prevention of Sudden Cardiac DeathImplantable Cardioverter Defibrillator

Investigational drug(s) / intervention(s)

ICD implantationNo ICD implantation

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

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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)

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)

FacilityCityRegionStatus
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
Official registry record

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