Following people with cardiac amyloidosis to learn how the disease progresses
Tracks how cardiac amyloidosis, a rare heart disease, progresses in adults over time.
Key facts
- Who runs it
- Leiden University Medical Center
- Where
- Sagamihara, JapanSee the siteAlso in 4 other countries, 5 sites
- Trial code
- Registry title
- International Cardiac Amyloidosis Registry
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 30 Jun 2023
- Planned end
- Jul 2026
- Type of study
- Observational
- Record updated
- 25 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a confirmed diagnosis of AL or ATTR cardiac amyloidosis, a disease where protein builds up in the heart muscle.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- AL or ATTR cardiac amyloidosis, diagnosed using heart signs, ECG, echo or heart MRI, blood tests, bone scan (Perugini stage 0 to 3) and, in some cases, a tissue biopsy.
- Biomarker or test result
- Hematological (blood) test and bone scintigraphy (Perugini stage) results that fit AL or ATTR amyloidosis; biopsy with subtyping in some cases.
Main reasons for not taking part
- Cannot give informed consent because of limited language skills or intellectual ability
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Unable to provide informed consent due to insufficient language proficiency or intellectual capabilities
Where in Japan
Also in 4 other countries, 5 sites
- Kitasato University HospitalSagamihara, JapanContact: Takeru Nabeta, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- CA
Patients diagnosed with cardiac amyloidosis. Either ATTR-CA or AL-CA.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- International Cardiac Amyloidosis Registry
- Plain-language title
- Following people with cardiac amyloidosis to learn how the disease progressesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 March 2025