NCT06894290 International Cardiac Amyloidosis Registry
| NCT ID | NCT06894290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Cardiac Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2026-07 |
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 300 participants in total. It began in 2023-06-30 with a primary completion date of 2026-07.
⚠ 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
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 are several variants. Each variant involves protein accumulation between heart muscle cells. This leads to the heart stiffening and, as a result, the heart has a hard time filling. This can lead to heart failure with complaints such as fluid retention, cardiac arrhythmias such as atrial fibrillation, conduction abnormalities that sometimes require a pacemaker, and clot formation in the heart that can cause a stroke and narrowing of the aortic valve. Getting the correct diagnosis is important because specific treatment is available in some cases for the different variants of cardiac amyloidosis. This research is needed to better understand the course of this disease profile and which patients respond well to the specific treatment. The aim of this research is to find out more about the course of the cardiac amyloidosis disease. The investigators see to what extent patients deteriorate in their condition due to the disease and how often they need to be hospitalized. Furthermore, the investigators want to learn to what extent certain abnormalities (on e.g. cardiac ultrasound) can predict how quickly clinical deterioration occurs. Finally, for certain forms of cardiac amyloidosis there is a specific drug treatment. Through this research, the investigators want to try to determine who really benefits from the specific medication in order to prescribe it to the right patients.
Eligibility 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
Contact & Investigator
Nina Ajmone Marsan, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06894290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT06894290 currently recruiting?
Yes, NCT06894290 is actively recruiting participants. Contact the research team at N.ajmone@lumc.nl for enrollment information.
Where is the NCT06894290 trial being conducted?
This trial is being conducted at Bruges, Belgium, Edegem, Belgium, Roma, Italy, Sagamihara, Japan and 2 additional locations.
Who is sponsoring the NCT06894290 clinical trial?
NCT06894290 is sponsored by Leiden University Medical Center. The principal investigator is Nina Ajmone Marsan, MD, PhD at Leiden University Medical Center. The trial plans to enroll 300 participants.