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

NCT ID: NCT05373940

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2030-05-31

Brief Summary

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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.

Detailed Description

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Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.

Main objective 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.

Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.

Conditions

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Heart Failure Primary Prevention of Sudden Cardiac Death Implantable Cardioverter Defibrillator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Heart failure optimal therapy alone (HFOT)

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.

Group Type EXPERIMENTAL

No ICD implantation

Intervention Type 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 (HFOT) + Implantable cardioverter defibrillator (ICD)

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.

Group Type ACTIVE_COMPARATOR

ICD implantation

Intervention Type 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.

Interventions

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ICD implantation

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.

Intervention Type DEVICE

No ICD implantation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥70 years old,
* Left ventricular ejection fraction ≤ 35%
* NYHA class II or III
* Heart failure HFOT ≥ 3 months
* Providing informed consent
* Affiliated to a French Health Insurance system.

Exclusion Criteria

* Enrolled in or planning to enroll in a conflicting interventional trial
* 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
* 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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eloi MARIJON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital européen Georges Pompidou, Paris

Rodrigue GARCIA, MD, PhD

Role: STUDY_DIRECTOR

CHU Poitiers, France

Locations

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Centre Hospitalier d'Aix en provence

Aix-en-Provence, , France

Site Status RECRUITING

CHU Amiens-Picardie-Site sud

Amiens, , France

Site Status RECRUITING

HôpitalHenri Mondor

Créteil, , France

Site Status RECRUITING

CHU Grenoble Alpes

La Tronche, , France

Site Status RECRUITING

Groupement d'Hôpitaux de l'Institut Catholique de Lille

Lomme, , France

Site Status RECRUITING

Hôpital de La Timone

Marseille, , France

Site Status RECRUITING

Hôpital de Brabois

Nancy, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Hôpital Privé du Confluent

Nantes, , France

Site Status RECRUITING

Hôpital européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Hôpital Pitié-Salpétrière

Paris, , France

Site Status RECRUITING

Hôpital Bichat - Claude Bernard

Paris, , France

Site Status RECRUITING

CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Hôpital Pontchaillou

Rennes, , France

Site Status RECRUITING

CHU de Rouen

Rouen, , France

Site Status RECRUITING

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

Hôpital Trousseau

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexandra BRUNEAU, Mrs

Role: CONTACT

[email protected]
+33144841712

Eloi MARIJON, MD, PhD

Role: CONTACT

[email protected]
+33156093692

Facility Contacts

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Jérôme TAIEB, MD

Role: primary

Otilia BUICIUC, MD

Role: primary

Nicolas LELLOUCHE, MD, PhD

Role: primary

Pascal DEFAYE, MD, PhD

Role: primary

Aymeric MENET, MD

Role: primary

Jean Claude DEHARO, MD, PhD

Role: primary

Hugues BLANGY, MD

Role: primary

Vincent PROBST, MD, PhD

Role: primary

Daniel GRAS, MD

Role: primary

Eloi MARIJON, MD, PhD

Role: primary

Estelle GANDJBAKHCH, MD, PhD

Role: primary

Fabrice EXTRAMIANA, MD, PhD

Role: primary

Rodrigue Garcia, MD, PhD

Role: primary

Vincent GALAND, MD

Role: primary

Frédéric ANSELME, MD, PhD

Role: primary

Olivier PIOT, MD

Role: primary

Laurence JESEL-MOREL, MD, PhD

Role: primary

Serge BOVEDA, MD, PhD

Role: primary

Laurent FAUCHIER, MD

Role: primary

Other Identifiers

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2021-A01959-32

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200035

Identifier Type: -

Identifier Source: org_study_id