Healthcare European Amyloidosis Registry
Registre HEAR, Healthcare European Amyloidosis Registry
This study is collecting information from patients with cardiac amyloidosis to better understand how the disease affects them over time without changing their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Saving Lives Matters Research network |
| Locations | 1 site (Créteil) |
| Trial ID | NCT05101304 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on patients with confirmed or suspected cardiac amyloidosis without interfering with their management. It includes three cohorts: a retrospective cohort of deceased patients, a retro-prospective cohort of patients already diagnosed, and a prospective cohort of patients referred for suspected amyloidosis. The study will gather information related to patient management throughout their follow-up, allowing for a comprehensive understanding of the disease's impact and progression.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed or suspected diagnosis of cardiac amyloidosis.
Not a fit: Patients who have expressed refusal to participate or are involved in other interventional studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of cardiac amyloidosis and improve patient management strategies.
How similar studies have performed: Other observational studies have successfully gathered valuable data on rare diseases, suggesting that this approach could yield meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Créteil
- Hôpital Henri Mondor — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Thibaud Pr Damy — Henri Mondor University Hospital
- Study coordinator: Mounira Kharoubi
- Email: mounira.kharoubi@gmail.com
- Phone: +33650029257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.