Registry for patients with cardiac amyloidosis
International Cardiac Amyloidosis Registry
This study is collecting information from adults with cardiac amyloidosis to see how the disease progresses and to help improve treatment and care for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 6 sites (Bruges and 5 other locations) |
| Trial ID | NCT06894290 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect real-world data on the diagnostic process, management, and outcomes of patients diagnosed with cardiac AL or ATTR amyloidosis. By evaluating the progression of the disease and identifying clinical and echocardiographic predictors of prognosis, the study seeks to enhance understanding of this underdiagnosed condition. Patients over 18 years old who meet specific diagnostic criteria will be included, and their health outcomes will be monitored over time. The study will help inform treatment strategies and improve patient care.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults over 18 years old diagnosed with cardiac AL or ATTR amyloidosis.
Not a fit: Patients who do not meet the diagnostic criteria for cardiac amyloidosis or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis and treatment strategies for patients with cardiac amyloidosis.
How similar studies have performed: Other studies have shown success in collecting real-world data for similar conditions, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * Unable to provide informed consent due to insufficient language proficiency or intellectual capabilities
Where this trial is running
Bruges and 5 other locations
- AZ St Jan — Bruges, Belgium (Recruiting)
- UZ Antwerpen — Edegem, Belgium (Recruiting)
- Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Roma — Roma, Italy (Recruiting)
- Kitasato University Hospital — Sagamihara, Japan (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Santa Marta Hospital, CHULC, Lisbon — Lisbon, Portugal (Recruiting)
Study contacts
- Principal investigator: Nina Ajmone Marsan, MD, PhD — Leiden University Medical Center
- Study coordinator: Nina Ajmone Marsan, MD, PhD
- Email: N.ajmone@lumc.nl
- Phone: +31715262020
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.