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

NCT05373940 | Recruiting DMC

• 2 other identifiers: APHP2000352021-A01959-32
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 19

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.

Conditions

Heart Failure; Primary Prevention of Sudden Cardiac Death; Implantable Cardioverter Defibrillator

Keywords

Heart Failure; Prevention strategy of Sudden Cardiac Death; Implantable cardioverter defibrillator; Heart Failure Optimal Therapy; Mortality

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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.

  48 months after randomization

Secondary Outcomes (9)

• Cardiovascular mortality

  48 months after randomization

• Sudden cardiac death and death from ventricular arrhythmias

  48 months after randomization

• Unplanned hospitalization due to cardiovascular causes

  48 months after randomization

• ICD related complications including inappropriate therapies

  48 months after randomization

• Global quality of life score with 36-Item Short Form Survey (SF36)

  baseline, 6, 12, 24, 36 and 48 months

Study Arms (2)

Heart failure optimal therapy alone (HFOT)

EXPERIMENTAL

Heart failure Optimal therapy without implantable cardioverter defibrillator. This group will not undergo an ICD implantation. They will be treated according to the HFOT recommended in the latest guidelines.

Device: No ICD implantation

Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD)

ACTIVE COMPARATOR

Optimal medical therapy + implantable cardioverter defibrillator (HFOT+ICD). This group will undergo an ICD implantation (standard of care), any brand, CE marked, implantable (lifelong), available and reimbursed in the French market (the type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization.

Device: ICD implantation

Interventions

ICD implantation DEVICE

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.

Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD)

No ICD implantation DEVICE

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.

Heart failure optimal therapy alone (HFOT)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥70 years old,
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (19)

Centre Hospitalier d'Aix en provence

Aix-en-Provence, 13616, France

RECRUITING

CHU Amiens-Picardie-Site sud

Amiens, 80054, France

RECRUITING

CHU Brest - Hôpital La Cavale Blanche

Brest, 29200, France

RECRUITING

HôpitalHenri Mondor

Créteil, 94000, France

RECRUITING

CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

Groupement d'Hôpitaux de l'Institut Catholique de Lille

Lomme, 59462, France

RECRUITING

Hôpital de La Timone

Marseille, 13385, France

RECRUITING

Hôpital de Brabois

Nancy, 54710, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Hôpital européen Georges Pompidou

Paris, , 75015, France

RECRUITING

Hôpital Pitié-Salpétrière

Paris, 75013, France

RECRUITING

Hôpital Bichat - Claude Bernard

Paris, 75014, France

RECRUITING

CHU Poitiers

Poitiers, 86021, France

RECRUITING

Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

CHU de Rouen

Rouen, 76000, France

RECRUITING

Centre Cardiologique du Nord

Saint-Denis, 93207, France

RECRUITING

CHU Strasbourg

Strasbourg, 67200, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

Hôpital Trousseau

Tours, 37170, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eloi MARIJON, MD, PhD

  AP-HP, Hôpital européen Georges Pompidou, Paris

  PRINCIPAL INVESTIGATOR

• Rodrigue GARCIA, MD, PhD

  CHU Poitiers, France

  STUDY DIRECTOR

Central Study Contacts

Alexandra BRUNEAU, Mrs

CONTACT

+33144841712; alexandra.bruneau@aphp.fr

Eloi MARIJON, MD, PhD

CONTACT

+33156093692; eloi.marijon@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Three experts in cardiac electrophysiology and ICD will be in charge of uniformly approving, while blinded to the study group, ICD tracings, cardiovascular events, including specific causes of death, in order to validate the primary and secondary endpoints.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 13, 2022
• Study Start: June 29, 2022
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasability and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (19)