Evaluating heart failure treatment options for patients over 70 to prevent sudden cardiac death

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine if optimal heart failure therapy alone is as effective as combining it with an implantable cardioverter defibrillator (ICD) for preventing sudden cardiac death in patients aged 70 and older. It is a randomized, open-label, multicenter trial involving 730 participants over four years, with a follow-up period of 48 months. The study will compare overall survival rates between two groups: one receiving optimal therapy alone and the other receiving optimal therapy plus ICD implantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥70 years old,
* Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).
* NYHA class II or III
* Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)
* Providing informed consent
* Affiliated to a French Health Insurance system.

Exclusion Criteria:

* Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)
* 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 (cerebrovascular disease with functional repercussions or effect on the patient's autonomy)
* 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)

Where it's running

• Centre Hospitalier d'Aix en provence
  Aix-en-Provence, France Recruiting
• CHU Amiens-Picardie-Site sud
  Amiens, France Recruiting
• CHU Brest - Hôpital La Cavale Blanche
  Brest, France Recruiting
• HôpitalHenri Mondor
  Créteil, France Recruiting
• CHU Grenoble Alpes
  La Tronche, France Recruiting
• Groupement d'Hôpitaux de l'Institut Catholique de Lille
  Lomme, France Recruiting

Study contacts

• Principal investigator: Eloi MARIJON, MD, PhD — AP-HP, Hôpital européen Georges Pompidou, Paris
• Study coordinator: Alexandra BRUNEAU, Mrs
• Email: alexandra.bruneau@aphp.fr
• Phone: +33144841712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.