ClinicalTrials.gov record NCT06894290

International Cardiac Amyloidosis Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

International Cardiac Amyloidosis Registry

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationBelgium, Italy, Japan, Netherlands, Portugal
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A prospective international registry collecting real-world clinical and imaging data from adults diagnosed with AL or ATTR cardiac amyloidosis. The study follows patients according to usual clinical care, records outcomes such as death, heart-failure hospitalization, and cardiovascular events, and shares anonymized data within the consortium. No extra visits are planned beyond routine care.

What it is studying. The study aims to learn how cardiac amyloidosis progresses in real-world practice, which clinical and echocardiographic findings predict worse outcomes, and which patients may benefit from specific treatments.

What the researchers hope to learn. To describe the diagnostic process and real-world outcomes for patients with cardiac AL and ATTR amyloidosis; to identify clinical and echocardiographic predictors of prognosis; and to help define which patients may benefit from specific therapies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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, specific treatment has become available for patients fulfilling certain criteria with good results in clinical trials. The rationale behind this prospective registry is to collect real-world data on diagnostic process, management, progression of disease and outcome of patients with cardiac AL and ATTR amyloidosis who are treated following local standards and to obtain (echocardiographic) predictors of prognosis in these patients. Objective: The objective of the study is to evaluate the diagnostic process from onset symptoms to diagnosis, the outcome in a real-world cohort of amyloidosis patients and to find predictors (both clinical and echocardiographic) of outcome Study design: Prospective long-term observational study Study population: All patients >18 years old, prospectively diagnosed with cardiac AL or ATTR amyloidosis Intervention (if applicable): n/a Main study parameters/endpoints: The main study endpoints are death, heart failure hospitalization and cardiovascular events Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients who participate in the registry will undergo structured follow up according to the clinical care pathway for amyloidosis patients based on the recommendations in the most recent Position Statement from the European Society of Cardiology [1]. There will be no additional visits planned, therefore no additional burden is associated with participation in the registry. Patients agree that their anonymized data is shared with other centers within the amyloidosis consortium.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, you give consent for the study team to collect and share your anonymized routine medical data with other centers in the amyloidosis consortium. Participants are followed according to the usual structured clinical care pathway for amyloidosis (no extra study visits are planned) and the registry records outcomes such as death, heart-failure hospitalizations, and other cardiovascular events over the planned follow-up (target duration 2 years). The registry will collect diagnostic, management and imaging information from routine care (for example echocardiography) to look for predictors of outcome. The registry requires that you already have a diagnosis of AL or ATTR cardiac amyloidosis made following the European Society of Cardiology recommendations (which may have involved tests such as bone scintigraphy, MRI, or biopsy); the record does not say the study itself performs those diagnostic tests.

How the study is structured. This is a prospective observational registry. Adults diagnosed with AL or ATTR cardiac amyloidosis are included and their medical and imaging data are collected over time while they receive local standard care. There are no experimental treatments assigned by the study, and no additional study visits are planned. Collected data are anonymized and shared among participating centers.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Belgium, Italy, Japan, Netherlands, Portugal. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under AL amyloidosis and wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 30, 2023
Primary completion
July 2026 (estimated)
Study completion
July 2026 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
Mar 25, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Leiden University Medical Center
Principal investigator
Nina Ajmone Marsan, MD, PhD
Leiden University Medical Center
Collaborators
  • Pfizer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

Terms used on this page · explanations by MedicalUpdates.ai

ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
endpoints
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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