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This is a non-interventional, prospective, retrospective, non-comparative, multi-center study.
In order not to interfere with patient management, the study is observational. Thus, no follow-up visit is imposed. The data collection will be limited to the data related to the management of the patients included throughout their follow-up.
This study is intended for all patients with a confirmed or suspected diagnosis of cardiac amyloidosis. Three cohorts will be identified: the HEAR (Healthcare European Amyloidosis Registry)-Retrospective Cohort, the HEAR(Healthcare European Amyloidosis Registry)-Retrospective-Prospective Cohort and the HEAR (Healthcare European Amyloidosis Registry)-Prospective Cohort.
Full description
Amyloidosis is a rare disease characterized by infiltration and continuous accumulation of insoluble fibrillar proteins in the extracellular matrix in various organs including kidney, nerve, liver, heart and skeletal muscle. Its prevalence is estimated at 0.5-1.3/100,000. The main forms are:
There is a strong need to help physicians better characterize the clinical and biological presentations of the disease and to improve diagnostic tools and standardize therapeutic management.
All data collected for the study are key, routine data for the condition, readily available in the patients' medical records. It is also possible to use additional and specific computerized tools to collect these data, within the participating expert centers.
Data will be recorded in an electronic observation book.
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Patients must meet all of the following inclusion criteria to be included in the study:
Prospective Cohort:
Patients referred or who have been referred to the participating centre for suspected amyloidosis.
Patient who signed the patient information "Prospective Cohort" note
Retro-prospective Cohort:
Patient already followed in the center with a confirmed diagnosis of amyloidosis Patient who signed the "retro-prospective cohort" patient information note
Retrospective cohort:
Deceased patients followed in the center with a confirmed diagnosis of amyloidosis
Study participants will not be compensated for their participation
EXCLUSION CRITERIA The patient has expressed his/her refusal to participate Participation in another study, even an interventional one, is not a criterion for non-inclusion.
5,000 participants in 3 patient groups
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Central trial contact
Rébecca Gene; Mounira Kharoubi
Data sourced from clinicaltrials.gov
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