{"id":3418,"date":"2022-07-11T17:26:36","date_gmt":"2022-07-11T15:26:36","guid":{"rendered":"https:\/\/reseau-amylose.org\/rechercheamylose\/?page_id=3418"},"modified":"2025-02-06T18:13:21","modified_gmt":"2025-02-06T17:13:21","slug":"quest-ce-que-le-registre-hear","status":"publish","type":"page","link":"https:\/\/reseau-amylose.org\/rechercheamylose\/quest-ce-que-le-registre-hear\/","title":{"rendered":"Qu’est-ce que le Registre HEAR ?"},"content":{"rendered":"\t\t
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Qu'est-ce que le Registre HEAR ?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Healthcare European Amyloidosis Registry<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Registre HEAR Introduction<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Amyloidosis is a rare disease characterized by the infiltration and continuous accumulation of insoluble fibrillar proteins in the extracellular matrix in various organs including kidneys, nerves, liver, heart and skeletal muscles. The prognosis of the disease is most often related to cardiac involvement. Unfortunately, it is often diagnosed late, which makes prognosis worse. This delay is due to a lack of simple diagnostic tools (biomarkers, imaging, etc.) to diagnose the disease. The lack of early diagnostic tools, the heterogeneity of the expression (multi systemic) of this pathology and the difficulty of its management lead to delays in diagnosis and failure to deal with certain organ damage and impair the patients\u2019 quality of life. There is a strong need to help physicians better characterize the clinical and biological presentations of the disease and to improve the tools for diagnosis.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Les derni\u00e8res donn\u00e9es de l'observatoire HEAR<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Mounira KHAROUBI<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Registre HEAR's Justification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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National registers and observatories are a major tool for improving the quality of care. They make care practices available to the whole community and their evolution over time is key to improving healthcare. This is particularly true in the field of cardiology. It has been shown that countries with long-standing national registers, such as Sweden, have improved their practices more rapidly than those countries that have done so later, such as the United Kingdom (Chung et al. Lancet 2014). This faster improvement in practices also improved survival amongst the populations studied (Chung et al., Lancet 2014). HEAR will be the first registry including all types of cardiac amyloidosis, and also patients for whom the diagnosis of amyloidosis was not retained thus making it possible to evaluate the path and the quality of diagnostic tools. After gathering information from French centers, HEAR will be extended to other centers in Europe and the World.The main objectives of this registry are to collect medical data, prognosis, treatments and quality of life of patients with cardiac amyloidosis to improve diagnosis and management. HEAR will give the opportunity to monitor new treatments adverse events as requested in Phase IV studies for post-marketing surveillance.In this register, we will include more than 5000 patients over a period of 5 years in more than 25 French centers. The data collected will help to better understand the disease, the course of care, develop diagnostic and prognostic tools and improve the management of patients with amyloidosis.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Registre HEAR's Objectives<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Primary Objective<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Collaborative effort concerning Cardiac Amyloidosis to collect clinical data on the course of the disease and to improve health care quality across countries.\u00a0<\/span><\/p>

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Secondary Objective<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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To define the prevalence and incidence of different types of amyloidosis in France\u2022 To describe the diagnostic mode and its evolution over time\u2022 To evaluate the quality of diagnostic tools\u2022 To describe the demographic, quality of life (questionnaire), imaging, the clinical side and the biological and anatomopathological characteristics of the disease \u2022 To describe the prognosis of the disease\u2022 To describe the therapeutic management (cardiological and specific) and its evolution over time\u2022 To improve the care of patients by improving the knowledge of medical teams\u2022 Evaluation of the costs of the disease (hospitalization, treatment, care, etc.)\u2022 Evaluation of treatments\u2019 side effects\u00b7\u00a0\u00a0 To monitor new treatments adverse events as requested in Phase IV studies for post-marketing surveillance.\u00a0\u00a0<\/span><\/p>

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Collaborative effort on Cardiac Amyloidosis to collect data, track the course of the disease and improve healthcare quality across countries.<\/span><\/h6>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Registre HEAR's Methodology<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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It is a non-interventional, prospective and retrospective, non-comparative and multi-center study.<\/span><\/h6>
Data will be collected via an electronic case report form provided by our specialized partner, Medsharing.<\/span><\/h6>
It will include most cardiac centers dedicated to the management of heart failure or cardiomyopathies<\/span><\/h6>
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Registre HEAR's Governance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u00a0Several committees provide governance for the HEAR registry. The steering committee ensures the overall management of the study (administrative, scientific, data quality, etc.), any subject related to science will be advised by the scientific committee and the monitoring of data quality will be advised mainly by the industrial committee and in part by the patient association.\u00a0<\/span><\/h6>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Steering Committee<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Steering Committee makes decisions concerning the overall direction of the Project, and decides on the strategic orientations of the project.<\/span><\/p>

The Steering Committee arbitrates in the event of a breach by one of the Partners in its contractual obligations and decides on the consequences of this breach.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The Scientific Committee<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The mission of the scientific committee is as follows:<\/span><\/p>

\u00a0 \u00a0 \u00a0– To provide scientific expertise, assistance and advice for the preparation and follow-up of the Study; proofreading and validation of the protocol and the questionnaire for the Study<\/span><\/p>

\u00a0 \u00a0 \u00a0– To advise the sponsor in the selection and recruitment of participating investigative centers<\/span><\/p>

\u00a0 \u00a0 \u00a0– To provide depending on the subject, if necessary, a presentation during meetings,<\/span><\/p>

\u00a0 \u00a0 \u00a0 – To participate in monitoring the progress of the Study in France, the motivation of the investigative teams,<\/span><\/p>

\u00a0 \u00a0 \u00a0– To participate in a data review and validation meeting before launching statistical analyses, validation of the final analysis plan<\/span><\/p>

\u00a0 \u00a0 \u00a0– To participate in a meeting to review the results, review and validate the study report.<\/span><\/p>

\u00a0 \u00a0 \u00a0– To participate in meetings to prepare the scientific communication of the results, excluding the writing of publications.<\/span><\/p>

The members of the committee will be elected by the steering committee at the beginning of the project from the principal investigator of centers that will participate in HEAR.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The Consultative Committee<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The consultative committee brings together the 2 expert committees.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\tSite internet du Registre HEAR\t\t\t\t\t<\/h2>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
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Amylo-HEAR-Young<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Damien GUIJARRO<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Amylo-HEAR-Old<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Antoine JOBBE-DUVAL<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Amylo-iSGLT2<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Thibaud DAMY<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Amylo-HEAR-V122I<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Jocelyn INAMO<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Amylo-FA'blation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Julien JEANNETEAU<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Qu’est-ce que le Registre HEAR ? Healthcare European Amyloidosis Registry Registre HEAR Introduction Amyloidosis is a rare disease characterized by the infiltration and continuous accumulation of insoluble fibrillar proteins in the extracellular matrix in various organs including kidneys, nerves, liver, heart and skeletal muscles. The prognosis of the disease is most often related to cardiac […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[],"tags":[],"class_list":["post-3418","page","type-page","status-publish","hentry"],"yoast_head":"\nQu'est-ce que le Registre HEAR ? - R\u00e9seau Amylose Recherche<\/title>\n<meta name=\"description\" content=\"Le registre HEAR - Healthcare European Amyloidosis Registry - registre national de recherche pour l'amylose cardiaque\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/reseau-amylose.org\/rechercheamylose\/quest-ce-que-le-registre-hear\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qu'est-ce que le Registre HEAR ? 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