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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05373940
Other study ID # APHP200035
Secondary ID 2021-A01959-32
Status Recruiting
Phase N/A
First received
Last updated
Start date June 29, 2022
Est. completion date May 31, 2030

Study information

Verified date November 2022
Source Assistance Publique - Hôpitaux de Paris
Contact Alexandra BRUNEAU, Mrs
Phone +33144841712
Email alexandra.bruneau@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.


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 ≥ 75 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 information / eligibility

Status Recruiting
Enrollment 730
Est. completion date May 31, 2030
Est. primary completion date May 31, 2030
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - =75 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
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.

Locations

Country Name City State
France Centre Hospitalier d'Aix en provence Aix-en-Provence
France CHU Amiens-Picardie-Site sud Amiens
France HôpitalHenri Mondor Créteil
France CHU Grenoble Alpes La Tronche
France Groupement d'Hôpitaux de l'Institut Catholique de Lille Lomme
France Hôpital de La Timone Marseille
France Hôpital de Brabois Nancy
France CHU de Nantes Nantes
France Hôpital Privé du Confluent Nantes
France Hôpital Bichat - Claude Bernard Paris
France Hôpital européen Georges Pompidou Paris
France Hôpital Pitié-Salpétrière Paris
France CHU Poitiers Poitiers
France Hôpital Pontchaillou Rennes
France CHU de Rouen Rouen
France Centre Cardiologique du Nord Saint Denis
France CHU Strasbourg Strasbourg
France Clinique Pasteur Toulouse
France Hôpital Trousseau Tours

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cardiovascular mortality Rate of cardiovascular mortality assessed by a blinded endpoint committee. 48 months after randomization
Secondary Sudden cardiac death and death from ventricular arrhythmias Rate of sudden cardiac death and rate of death from ventricular arrhythmias assessed by a blinded endpoint committee. 48 months after randomization
Secondary Unplanned hospitalization due to cardiovascular causes Number of unplanned hospitalization due to cardiovascular causes 48 months after randomization
Secondary ICD related complications including inappropriate therapies Number of ICD related therapies (antitachycardia pacing and shocks), hematoma, infection related to the device, lead dislodgement requiring intervention, pneumothorax and tamponade. 48 months after randomization
Secondary Global quality of life score with 36-Item Short Form Survey (SF36) 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. baseline, 6, 12, 24, 36 and 48 months
Secondary Health-related quality of life score Euroqol EQ-5D questionnaire 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) baseline, 6, 12, 24, 36 and 48 months
Secondary Patient's global self-assessment of heart failure-related quality of life score 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. baseline, 6, 12, 24, 36 and 48 months
Secondary The Incremental cost-utility ratio. (ICUR) 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. 48 months
Secondary The incremental cost-effectiveness ratio (ICER) 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. 48 months
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