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Clinical Trials in Italy / NCT06866912
Recruiting Observational

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

NCT06866912 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-09-01
Last updated
2025-03-10

Condition(s) studied

Cardiomyopathy

Study summary

observational epidemiological study of patients affected by systemic amyloidosis

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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 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 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 pacemaker implantation of defibrillator — throughout the study period until 10 years
    incidence during follow-up of need for defibrillator implantation
  • Incidence of cardiac transplantation — throughout the study period until 10 years
    incidence during follow-up of need for cardiac transplantation
  • 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
  • Mortality — throughout the study period until 10 years
    total mortality during follow up

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06866912 on ClinicalTrials.gov ↗ ← All trials in Italy