International Cardiac Amyloidosis Registry

Recruiting now

Conditions studied: Cardiac Amyloidosis

In brief

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.

Key facts

Study ID: NCT06894290
Run by: Leiden University Medical Center
People needed: 300
Starts: 2023-06-30
Expected to finish: 2026-07-01
Last updated by the study team: 2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Unable to provide informed consent due to insufficient language proficiency or intellectual capabilities

Where it is running

AZ St Jan — Bruges, Belgium (enrolling)
UZ Antwerpen — Edegem, Belgium (enrolling)
Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Roma — Roma, Italy (enrolling)
Kitasato University Hospital — Sagamihara, Japan (enrolling)
Leiden University Medical Center — Leiden, Netherlands (enrolling)
Santa Marta Hospital, CHULC, Lisbon — Lisbon, Portugal (enrolling)

Full record on ClinicalTrials.gov

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