Clinical trial NCT05373940: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Official title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-05-13
Enrollment: 730
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
timeFrame: 48 months after randomization
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 48 months after randomization
measure: Sudden cardiac death and death from ventricular arrhythmias
timeFrame: 48 months after randomization
measure: Unplanned hospitalization due to cardiovascular causes
timeFrame: 48 months after randomization
measure: ICD related complications including inappropriate therapies
timeFrame: 48 months after randomization
measure: Global quality of life score with 36-Item Short Form Survey (SF36)
timeFrame: baseline, 6, 12, 24, 36 and 48 months
measure: Health-related quality of life score Euroqol EQ-5D questionnaire
timeFrame: baseline, 6, 12, 24, 36 and 48 months
measure: Patient's global self-assessment of heart failure-related quality of life score
timeFrame: baseline, 6, 12, 24, 36 and 48 months
measure: The Incremental cost-utility ratio. (ICUR)
timeFrame: 48 months
measure: The incremental cost-effectiveness ratio (ICER)
timeFrame: 48 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier d'Aix en provence
city: Amiens
country: France
facility: CHU Amiens-Picardie-Site sud
city: Créteil
country: France
facility: HôpitalHenri Mondor
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lomme
country: France
facility: Groupement d'Hôpitaux de l'Institut Catholique de Lille
city: Marseille
country: France
facility: Hôpital de La Timone
city: Nancy
country: France
facility: Hôpital de Brabois
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: AP-HP, Hôpital européen Georges Pompidou, Paris
name: Eloi MARIJON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Poitiers, France
name: Rodrigue GARCIA, MD, PhD
role: STUDY_DIRECTOR
References: