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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
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier d'Aix en Provence
Coordinator of this site? Confirm its status
Aix-en-ProvenceFranceRecruiting
CHU Amiens-Picardie - Site Sud
Coordinator of this site? Confirm its status
AmiensFranceRecruiting
CHU Brest, Hopital La Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceRecruiting
HôpitalHenri Mondor
Coordinator of this site? Confirm its status
CréteilFranceRecruiting
Chu Grenoble Alpes
Coordinator of this site? Confirm its status
La TroncheFranceRecruiting
Groupement d'Hôpitaux de l'Institut Catholique de Lille
Coordinator of this site? Confirm its status
LommeFranceRecruiting
Hopital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Hôpital de Brabois
Coordinator of this site? Confirm its status
NancyFranceRecruiting
CHU de Nantes
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NantesFranceRecruiting
Hopital Pitie-Salpetriere
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ParisFranceRecruiting
Hôpital Bichat - Claude-Bernard
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ParisFranceRecruiting
Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
CHU Poitiers
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PoitiersFranceRecruiting
Hôpital Pontchaillou
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RennesFranceRecruiting
CHU de Rouen
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RouenFranceRecruiting
Centre Cardiologique du Nord
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Saint-DenisFranceRecruiting
CHU Strasbourg
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StrasbourgFranceRecruiting
Clinique Pasteur
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ToulouseFranceRecruiting
Hôpital TROUSSEAU
Coordinator of this site? Confirm its status
ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.