Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

Recruiting

• Conditions: Cardiomyopathy

• Registration Number: NCT06866912
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

observational epidemiological study of patients affected by systemic amyloidosis

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-10
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2033-08-31
• Study Completion: 2033-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of amyloidosis	throughout the study period until 10 years	prevalence of amyloidosis in patients admitted to the UOs participating in the study
incidence of amyloidosis	throughout the study period until 10 years	incidence of amyloidosis in patients admitted to the UOs participating in the study
Observational epidemiological study of patients with systemic amyloidosis	throughout the study period until 10 years	characteristics of each etiology in terms of baseline clinical data
Types of cardiac clinical phenotype	throughout the study period until 10 years	Cardiac clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of mixed clinical phenotype	throughout the study period until 10 years	Mixed clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of hospitalization for stroke	throughout the study period until 10 years	Incidence of hospitalization for stroke during follow-up
incidence of pacemaker implantation	throughout the study period until 10 years	incidence during follow-up of need for pacemaker implantation
Incidence of cardiac transplantation	throughout the study period until 10 years	incidence during follow-up of need for cardiac transplantation
Mortality	throughout the study period until 10 years	total mortality during follow up
Incidence of hospitalization for heart failure	throughout the study period until 10 years	Incidence during follow-up of hospitalization for heart failure
Incidence of hospitalization for onset of arrhythmias	throughout the study period until 10 years	Incidence during follow-up of hospitalization for onset of arrhythmias
incidence of pacemaker implantation of defibrillator	throughout the study period until 10 years	incidence during follow-up of need for defibrillator implantation
Incidence of transplantation of other solid organs	throughout the study period until 10 years	incidence during follow-up of need for other solid organ transplantation

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy