Registre HEAR, Healthcare European Amyloidosis Registry

NCT05101304 | Recruiting

• 1 other identifier: HR01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• The clinical, biological and imaging characteristics of patients with cardiac amyloidosis

  Describe the clinical, biological and imaging characteristics of patients with cardiac amyloidosis.

  6 years

Secondary Outcomes (2)

• he prevalence and incidence of the different types of amyloidosis and their evolution.

  6 years

• The therapeutic management (cardiological and specific), their beneficial and secondary effects.

  6 years

Study Arms (3)

HEAR(Healthcare European Amyloidosis Registry)-Retrospective Cohort

Retrospective collection of deceased patients data with inclusion criteria

HEAR(Healthcare European Amyloidosis Registry)-Retrospective-Prospective Cohort

Retrospective and prospective collection of patient data and real-life follow-up of patients from the date of inclusion Living patients who met the inclusion criteria

HEAR(Healthcare European Amyloidosis Registry)-Prospective Cohort

Prospective data collection and real-life follow-up of patients from the date of inclusion These patients are either newly followed in the centre with the inclusion criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is intended for all patients with a confirmed or suspected diagnosis of cardiac amyloidosis.

You may qualify if:

• Major patient
• Protected adult patient (guardianship or curatorship)
• 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

Sponsors & Collaborators

• Saving Lives Matters: lead

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Thibaud Pr Damy

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mounira Kharoubi

CONTACT

+33650029257; mounira.kharoubi@gmail.com

Rébecca Gene

CONTACT

+33628274249; rebecca.gene@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 1, 2021
• Study Start: June 29, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)