Status:
RECRUITING
International Cardiac Amyloidosis Registry
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Cardiac Amyloidosis
Eligibility:
All Genders
18+ years
Brief Summary
Cardiac amyloidosis is a relatively rare disease. However, with the newer imaging techniques that have become available to us in recent years, determining the diagnosis is becoming more common. There ...
Detailed Description
Rationale: Patients with cardiac amyloidosis are in general underdiagnosed and undertreated. AL amyloidosis is a disease with a very poor prognosis if left untreated. For ATTR amyloidosis, recently, s...
Eligibility Criteria
Inclusion
- Diagnosed with AL or ATTR cardiac amyloidosis following the recommendations of the European Society of Cardiology \[1\] which include:
- Signs and symptoms, ECG, echo or CMR suggestive of cardiac amyloidosis and
- negative hematological test and bone scintigraphy Perugini stage 2 or 3 (is diagnostic for ATTR amyloidosis)
- negative hematological test and bone scintigraphy Perugini stage 1 and histological confirmation (either extracardiac or cardiac biopsy) with subtyping of ATTR amyloidosis
- positive hematological test and bone scintigraphy Perugini stage 1-3 and histological confirmation (usually cardiac biopsy) with subtyping of ATTR amyloidosis
- positive hematological rest and bone scintigraphy Perugini stage 0, MRI consistent with amyloidosis and histological confirmation (either extracardiac or cardiac biopsy) with subtyping AL amyloidosis
Exclusion
- Unable to provide informed consent due to insufficient language proficiency or intellectual capabilities
Key Trial Info
Start Date :
June 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06894290
Start Date
June 30 2023
End Date
July 1 2026
Last Update
March 25 2025
Active Locations (6)
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1
AZ St Jan
Bruges, Belgium, 8000
2
UZ Antwerpen
Edegem, Belgium, 2650
3
Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Roma
Roma, Italy, 00168
4
Kitasato University Hospital
Sagamihara, Japan, 252-0375