ClinicalTrials.gov record NCT06866912

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

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

This is an observational cohort study of adults diagnosed with systemic amyloidosis or who carry pathogenic transthyretin (TTR) gene mutations. Participants' clinical information and medical events will be recorded and followed for up to 10 years. The study aims to describe how common amyloidosis is and to document cardiac features and clinical outcomes in this population.

What it is studying. The study is measuring how common systemic amyloidosis is and how it progresses over time. It will collect clinical characteristics by cause, record cardiac clinical phenotypes (including in asymptomatic TTR mutation carriers), and track events such as hospitalizations for heart failure, arrhythmias, and stroke, device implantations, organ transplants, and deaths over a 10-year period.

What the researchers hope to learn. To estimate prevalence and incidence of systemic amyloidosis at the participating centers; to describe baseline clinical characteristics by etiology; to define cardiac clinical phenotypes and mixed phenotypes in mutation carriers; and to measure rates of hospitalization for heart failure, arrhythmias, stroke, pacemaker/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.

If you take part, the study will record baseline clinical information and follow you for up to 10 years. The study will document clinical outcomes and characteristics such as prevalence and incidence of amyloidosis, cardiac clinical phenotype in carriers, hospitalizations for heart failure, arrhythmias or stroke, pacemaker/defibrillator implantation, organ transplantation, and mortality. The registry does not list any study-specific procedures or extra tests; it only states that informed consent is required.

How the study is structured. An observational cohort study: participants' medical records and clinical data will be collected and followed over time (up to 10 years). No experimental treatments are given; investigators will record diagnoses, clinical features, hospital admissions, device implantations, transplants, and mortality to estimate prevalence, incidence, and outcomes.

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 ATTRv amyloidosis

This trial is also listed on this site under 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: 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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