ClinicalTrials.gov record NCT06866912

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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 to 99 years old

SexAll

LocationItaly

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 10-year observational cohort study of adults diagnosed with systemic amyloidosis or who are carriers of pathogenic transthyretin mutations. It will collect clinical information and follow participants to measure how common the disease is, describe clinical features, and record outcomes such as hospitalizations, device implantation, transplants, and death. This study does not assign treatments; it observes and records clinical outcomes.

What it is studying. The study collects and analyzes clinical and outcome data to estimate prevalence and incidence of systemic amyloidosis, to describe baseline clinical characteristics by etiology, to identify cardiac clinical phenotypes (including mixed phenotypes) in transthyretin mutation carriers, and to record incidence of hospitalizations (heart failure, arrhythmia, stroke), pacemaker/defibrillator implantation, organ transplantation, and mortality over up to 10 years.

What the researchers hope to learn. To estimate prevalence and incidence of amyloidosis in patients seen at participating centers; to describe baseline clinical characteristics by cause; to characterize cardiac clinical phenotypes among transthyretin mutation carriers; and to measure incidence of hospitalizations (heart failure, arrhythmia, stroke), pacemaker or defibrillator implantation, organ transplantation, and mortality during follow-up.

What this study is about

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

observational epidemiological study of patients affected by systemic amyloidosis

Eligibility

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

Inclusion criteria

patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene
minimum age of 18 years at the time of diagnosis
obtaining informed consent

Exclusion criteria

nothing

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

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.

This is an observational cohort study with up to 10 years of follow-up. Participants will have baseline clinical information recorded and will be followed over time so the study can track outcomes such as hospitalizations, arrhythmias, pacemaker/defibrillator implantation, organ transplants, and mortality. Participation requires giving informed consent and allowing the study team to collect and follow clinical data from medical records and routine care; the registry does not list specific study procedures (for example, it does not specify blood draws or imaging). Exact visit schedules and tests depend on the participating center and are not specified in the registry.

How the study is structured. An observational cohort study that follows adult patients and mutation carriers for up to 10 years. No study-assigned treatments are given; the study gathers medical data and outcomes from routine care and follow-up visits to document diagnoses and clinical events.

Questions you could ask

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

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 Italy. 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 wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Sep 1, 2023
Primary completion: Aug 31, 2033 (estimated)
Study completion: Aug 31, 2033 (estimated)
Target enrollment: 750 participants (estimated)
Last updated on registry: Mar 10, 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: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

simone longhi, MD 📞 00390512149039 ✉ simone.longhi@aosp.bo.it

Participating sites (1)

IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, 40138 · Italy
- Simone longhi, MD · 00390512149039 · simone.longhi@aosp.bo.it

Terms used on this page · explanations by MedicalUpdates.ai

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.

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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