NCT05373940 Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
| NCT ID | NCT05373940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 730 participants |
| Start Date | 2022-06-29 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 730 participants in total. It began in 2022-06-29 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Eloi MARIJON, MD, PhD
PRINCIPAL INVESTIGATOR
AP-HP, Hôpital européen Georges Pompidou, Paris
Frequently Asked Questions
Who can join the NCT05373940 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05373940 currently recruiting?
Yes, NCT05373940 is actively recruiting participants. Contact the research team at alexandra.bruneau@aphp.fr for enrollment information.
Where is the NCT05373940 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Amiens, France, Brest, France, Créteil, France and 11 additional locations.
Who is sponsoring the NCT05373940 clinical trial?
NCT05373940 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Eloi MARIJON, MD, PhD at AP-HP, Hôpital européen Georges Pompidou, Paris. The trial plans to enroll 730 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.