Evaluating heart failure treatment options for patients over 70 to prevent sudden cardiac death
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial
This study is testing whether adding an implantable defibrillator to standard heart failure treatment can help people over 70 live longer and avoid sudden cardiac death.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 730 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 19 sites (Aix-en-Provence and 18 other locations) |
| Trial ID | NCT05373940 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 70 and older with heart failure and a left ventricular ejection fraction of 35% or less.
Not a fit: Patients with advanced comorbidities or those who have recently experienced significant cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence to guide treatment decisions for elderly patients, potentially reducing unnecessary ICD implantations and associated complications.
How similar studies have performed: While there is limited data specifically for elderly patients, similar studies in younger populations have shown the effectiveness of ICDs, making this approach somewhat novel for the elderly demographic.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aix-en-Provence and 18 other locations
- 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)
- Hôpital de La Timone — Marseille, France (Recruiting)
- Hôpital de Brabois — Nancy, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- Hôpital européen Georges Pompidou — Paris, France (Recruiting)
- Hôpital Pitié-Salpétrière — Paris, France (Recruiting)
- Hôpital Bichat - Claude Bernard — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- Hôpital Pontchaillou — Rennes, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- CHU Strasbourg — Strasbourg, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Hôpital Trousseau — Tours, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.