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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 9, 2022

Keywords

ClinConnect Summary

The DILEMMA study is a clinical trial looking at two different treatment approaches for older patients with heart failure. Specifically, it aims to find out if managing heart failure with optimal therapy alone is just as effective as combining this therapy with an implantable cardioverter defibrillator (ICD) in preventing sudden cardiac death over four years. The trial focuses on patients who are 75 years and older and have a weakened heart that pumps less than 35% of blood effectively.

To be eligible for the trial, participants must be at least 75 years old, have been diagnosed with heart failure for three months or more, and have specific heart function measurements. It’s important that they can give informed consent and are covered by a French health insurance system. Participants in the study will be randomly assigned to one of the two treatment groups and will regularly check in with healthcare providers to monitor their health over the course of the study. This trial is currently recruiting participants and is significant because it could help determine the best way to protect older patients from sudden cardiac death.

Gender

ALL

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)