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NCT05373940 | Recruiting | Heart Failure


Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years
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 ≥ 75 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Condition or disease

Heart Failure

Primary Prevention of Sudden Cardiac Death

Implantable Cardioverter Defibrillator

Intervention/treatment

ICD implantation

No ICD implantation

Phase

Not Applicable

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 ≥ 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.

Study Type : Interventional
Estimated Enrollment : 730 participants
Masking: Single
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years: A Randomized Controlled Trial
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : May 31, 2030
Estimated Study Completion Date : May 31, 2030
Arm Intervention/treatment

Experimental: 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.

Device: No ICD implantation

Active Comparator: 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.

Device: ICD implantation

Ages Eligible for Study: 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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)

Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years

Location Details


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Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 75 Years

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

France,

Centre Hospitalier d'Aix en provence

Aix-en-Provence, France, 13616

Recruiting

France,

CHU Amiens-Picardie-Site sud

Amiens, France, 80054

Recruiting

France,

HôpitalHenri Mondor

Créteil, France, 94000

Recruiting

France,

CHU Grenoble Alpes

La Tronche, France, 38700

Recruiting

France,

Groupement d'Hôpitaux de l'Institut Catholique de Lille

Lomme, France, 59462

Recruiting

France,

Hôpital de La Timone

Marseille, France, 13385

Recruiting

France,

Hôpital de Brabois

Nancy, France, 54710

Recruiting

France,

CHU de Nantes

Nantes, France, 44093

Recruiting

France,

Hôpital Privé du Confluent

Nantes, France, 44277

Recruiting

France,

Hôpital européen Georges Pompidou

Paris, France, , 75015

Recruiting

France,

Hôpital Pitié-Salpétrière

Paris, France, 75013

Recruiting

France,

Hôpital Bichat - Claude Bernard

Paris, France, 75014

Recruiting

France,

CHU Poitiers

Poitiers, France, 86021

Recruiting

France,

Hôpital Pontchaillou

Rennes, France, 35033

Recruiting

France,

CHU de Rouen

Rouen, France, 76000

Recruiting

France,

Centre Cardiologique du Nord

Saint Denis, France, 93207

Recruiting

France,

CHU Strasbourg

Strasbourg, France, 67200

Recruiting

France,

Clinique Pasteur

Toulouse, France, 31076

Recruiting

France,

Hôpital Trousseau

Tours, France, 37170

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