HEAR: Healthcare European Amyloidosis Registry

Abstract

Amyloidosis is an under-recognized disease. The prognosis of the disease is related to cardiac involvement. Cardiac amyloidosis is often misdiagnosed or diagnosed late. Real world data on cardiac amyloidosis is missing (characteristics, management, and outcomes with and/or without treatment). Clinical trial populations differ from real life population. Phase IV studies on CA's treatments need adverse events monitoring and incidence of these events. The objectives of this registry HEAR are to collect medical and quality of life data from patients with cardiac amyloidosis including patients referred for suspicion of amyloidosis (controls) and every type of amyloidosis (hTTR, wt-TTR, AL, ApoA1..). HEAR will be the first registry including all patients referred for suspicion of cardiac amyloidosis. HEAR is a non-interventional study. Two types of data will be collected. Retrospective data from patients included in centers between 2009 and 2019 (» 2000 patients with their follow-up and outcomes). Prospective data: patients newly included (» 3000 patients). 25 centers in France dedicated to cardiac amyloidosis will participate to the registry. Including all these types of patients in our registry will allow us to collect a large amount of data to better understand the disease, the course of care, develop diagnostic and prognostic tools (comparative groups needed (AL and controls..)) and improve the management of patients with amyloidosis. The creation of the Registry HEAR will also offer the opportunity to set up post AMM project and facilitate inclusions in future therapeutic trials by a better knowledge of the population and the disease and also a base of centers and prescreened patients to achieve our goals faster. Our goal is to include more than 5000 patients over a period of 5 years in 25 French centers. HEAR, initiated in France, aims to expand quickly to other countries.