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Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06866912
Acronym
AMI-ER
Enrollment
750
Registered
2025-03-10
Start date
2023-09-01
Completion date
2033-08-31
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

Keywords

Cardiac amyloidosis

Brief summary

observational epidemiological study of patients affected by systemic amyloidosis

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of amyloidosisthroughout the study period until 10 yearsprevalence of amyloidosis in patients admitted to the UOs participating in the study
incidence of amyloidosisthroughout the study period until 10 yearsincidence of amyloidosis in patients admitted to the UOs participating in the study
Observational epidemiological study of patients with systemic amyloidosisthroughout the study period until 10 yearscharacteristics of each etiology in terms of baseline clinical data
Types of cardiac clinical phenotypethroughout the study period until 10 yearsCardiac clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of mixed clinical phenotypethroughout the study period until 10 yearsMixed clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of hospitalization for heart failurethroughout the study period until 10 yearsIncidence during follow-up of hospitalization for heart failure
Incidence of hospitalization for onset of arrhythmiasthroughout the study period until 10 yearsIncidence during follow-up of hospitalization for onset of arrhythmias
Incidence of hospitalization for strokethroughout the study period until 10 yearsIncidence of hospitalization for stroke during follow-up
incidence of pacemaker implantationthroughout the study period until 10 yearsincidence during follow-up of need for pacemaker implantation
incidence of pacemaker implantation of defibrillatorthroughout the study period until 10 yearsincidence during follow-up of need for defibrillator implantation
Incidence of cardiac transplantationthroughout the study period until 10 yearsincidence during follow-up of need for cardiac transplantation
Incidence of transplantation of other solid organsthroughout the study period until 10 yearsincidence during follow-up of need for other solid organ transplantation
Mortalitythroughout the study period until 10 yearstotal mortality during follow up

Countries

Italy

Contacts

Primary Contactsimone longhi, MD
simone.longhi@aosp.bo.it00390512149039

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026