Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
- Conditions
- Implantable Cardioverter DefibrillatorHeart FailurePrimary Prevention of Sudden Cardiac Death
- Interventions
- Device: No ICD implantationDevice: ICD implantation
- Registration Number
- NCT05373940
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 730
- ≥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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heart failure optimal therapy alone (HFOT) No ICD implantation 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. Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD) ICD implantation 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.
- Primary Outcome Measures
Name Time Method Overall survival 48 months after randomization 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.
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality 48 months after randomization Rate of cardiovascular mortality assessed by a blinded endpoint committee.
Sudden cardiac death and death from ventricular arrhythmias 48 months after randomization Rate of sudden cardiac death and rate of death from ventricular arrhythmias assessed by a blinded endpoint committee.
Unplanned hospitalization due to cardiovascular causes 48 months after randomization Number of unplanned hospitalization due to cardiovascular causes
ICD related complications including inappropriate therapies 48 months after randomization Number of ICD related therapies (antitachycardia pacing and shocks), hematoma, infection related to the device, lead dislodgement requiring intervention, pneumothorax and tamponade.
Global quality of life score with 36-Item Short Form Survey (SF36) baseline, 6, 12, 24, 36 and 48 months Global quality of life score with SF36 (Short form 36 health survey) : the norm data is 0-100, the health related quality of life is increased as the scores are increased.
Health-related quality of life score Euroqol EQ-5D questionnaire baseline, 6, 12, 24, 36 and 48 months Health-related quality of life measured by using the European Quality Of Life (EQ-5D) auto-questionnaire. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The visual analogue scale (VAS) records the patient's self-rated health on a vertical axis from 0 (worst health) to 100 (best health)
Patient's global self-assessment of heart failure-related quality of life score baseline, 6, 12, 24, 36 and 48 months The Minnesota Living with Heart Failure will be used to measure the subjects perception of how their heart failure affect their life. Norm data is 0-105 (21 items ; score 0-5), quality of life increases as scores decrease.
The Incremental cost-utility ratio. (ICUR) 48 months The ICUR is calculated by dividing the difference between the average costs of both groups by the difference in mean QALYs gained in both groups. The QALYs will be constructed with the EuroQoL-5D (EQ-5D) questionnaire and value sets.
The incremental cost-effectiveness ratio (ICER) 48 months The ICER will estimate the cost per additional survivor and is calculated by dividing the difference between the average costs of both groups by the difference in effectiveness (survival) between both groups.
Trial Locations
- Locations (19)
Centre Hospitalier d'Aix en provence
🇫🇷Aix-en-Provence, France
CHU Grenoble Alpes
🇫🇷La Tronche, France
CHU Strasbourg
🇫🇷Strasbourg, France
Hôpital Pitié-Salpétrière
🇫🇷Paris, France
CHU Amiens-Picardie-Site sud
🇫🇷Amiens, France
HôpitalHenri Mondor
🇫🇷Créteil, France
Hôpital européen Georges Pompidou
🇫🇷Paris, France
Groupement d'Hôpitaux de l'Institut Catholique de Lille
🇫🇷Lomme, France
Hôpital Bichat - Claude Bernard
🇫🇷Paris, France
Hôpital de Brabois
🇫🇷Nancy, France
Hôpital de La Timone
🇫🇷Marseille, France
Hôpital Pontchaillou
🇫🇷Rennes, France
CHU de Nantes
🇫🇷Nantes, France
CHU Poitiers
🇫🇷Poitiers, France
CHU de Rouen
🇫🇷Rouen, France
Hôpital Privé du Confluent
🇫🇷Nantes, France
Hôpital Trousseau
🇫🇷Tours, France
Clinique Pasteur
🇫🇷Toulouse, France
Centre Cardiologique du Nord
🇫🇷Saint Denis, France