NCT05373940Recruiting
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 730 (estimated)
- First submitted
- 20 Apr 2022
- Start date
- 29 Jun 2022
- Primary completion date
- 31 May 2030
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Heart failure
- NCT number
- NCT05373940
What you commit to
- Study type: Interventional
- Planned participants: 730
- From 29 Jun 2022 to the primary completion date, 31 May 2030
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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)
Who the study is looking for
- ≥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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier d'Aix en Provence Coordinator of this site? Confirm its status | Aix-en-Provence | France | Recruiting |
| CHU Amiens-Picardie - Site Sud Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| CHU Brest, Hopital La Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| HôpitalHenri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Chu Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| Groupement d'Hôpitaux de l'Institut Catholique de Lille Coordinator of this site? Confirm its status | Lomme | France | Recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital de Brabois Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Hôpital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Hôpital TROUSSEAU Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.