NCT05101304 Registre HEAR, Healthcare European Amyloidosis Registry
| NCT ID | NCT05101304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saving Lives Matters |
| Condition | Cardiac Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-06-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2021-06-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
INCLUSION CRITERIA 1. Patients must meet all of the following inclusion criteria to be included in the study: * Major patient * Protected adult patient (guardianship or curatorship) 2. 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 3. 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 4. 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.
Contact & Investigator
Thibaud Pr Damy
PRINCIPAL INVESTIGATOR
Henri Mondor University Hospital
Frequently Asked Questions
Who can join the NCT05101304 clinical trial?
This trial is open to participants of all sexes, studying Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05101304 currently recruiting?
Yes, NCT05101304 is actively recruiting participants. Contact the research team at mounira.kharoubi@gmail.com for enrollment information.
Where is the NCT05101304 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT05101304 clinical trial?
NCT05101304 is sponsored by Saving Lives Matters. The principal investigator is Thibaud Pr Damy at Henri Mondor University Hospital. The trial plans to enroll 5,000 participants.