Tests a defibrillator device in people aged 70 or older with heart failure
Compares a defibrillator device with heart failure medicines alone in people 70 or older.
Plain-language title generated from the registry record
Registry title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Key facts
- Where
- Aix-en-Provence, Amiens, Brest, Créteil, La Tronche, Lomme, Marseille, Nancy, Nantes, Paris, Poitiers, Rennes, Rouen, Saint-Denis, Strasbourg, Toulouse, and Tours, FranceSee the 19 sites
Where in France
- Centre Hospitalier d'Aix en ProvenceAix-en-Provence, FranceTaking people
- CHU Amiens-Picardie - Site SudAmiens, FranceTaking people
- CHU Brest, Hopital La Cavale BlancheBrest, FranceTaking people
- HôpitalHenri MondorCréteil, FranceTaking people
- Chu Grenoble AlpesLa Tronche, FranceTaking people
- Groupement d'Hôpitaux de l'Institut Catholique de LilleLomme, FranceTaking people
- Hopital de la TimoneMarseille, FranceTaking people
- Hôpital de BraboisNancy, FranceTaking people
- CHU de NantesNantes, FranceTaking people
- Hôpital Bichat - Claude-BernardParis, FranceTaking people
- Hôpital Européen Georges PompidouParis, FranceTaking people
- Hopital Pitie-SalpetriereParis, FranceTaking people
- CHU PoitiersPoitiers, FranceTaking people
- Hôpital PontchaillouRennes, FranceTaking people
- CHU de RouenRouen, FranceTaking people
- Centre Cardiologique du NordSaint-Denis, FranceTaking people
- CHU StrasbourgStrasbourg, FranceTaking people
- Clinique PasteurToulouse, FranceTaking people
- Hôpital TROUSSEAUTours, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05373940
- Record updated
- 24 March 2026
- Original description
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.Read full original descriptionShow less
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled 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.
Inclusion: ≥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: Prior unstable sustained ventricular arrhythmia requiring external cardioversion; Coronary artery intervention (catheter or surgical) within 90 days; History of syncope in the previous 6 months; Myocardial infarction within the 40 days; 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; 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); Patient under tutorship, curatorship, or legal safeguard; Persons deprived of their liberty by judicial or administrative decision (prisoner).