Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

NCT06866912 | Recruiting

• 1 other identifier: AMI-ER
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

observational epidemiological study of patients affected by systemic amyloidosis

Conditions

Cardiomyopathy

Keywords

Cardiac amyloidosis

Outcome Measures

Primary Outcomes (13)

• prevalence of amyloidosis

  prevalence of amyloidosis in patients admitted to the UOs participating in the study

  throughout the study period until 10 years

• incidence of amyloidosis

  incidence of amyloidosis in patients admitted to the UOs participating in the study

  throughout the study period until 10 years

• Observational epidemiological study of patients with systemic amyloidosis

  characteristics of each etiology in terms of baseline clinical data

  throughout the study period until 10 years

• Types of cardiac clinical phenotype

  Cardiac clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations

  throughout the study period until 10 years

• Incidence of mixed clinical phenotype

  Mixed clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations

  throughout the study period until 10 years

• Incidence of hospitalization for heart failure

  Incidence during follow-up of hospitalization for heart failure

  throughout the study period until 10 years

• Incidence of hospitalization for onset of arrhythmias

  Incidence during follow-up of hospitalization for onset of arrhythmias

  throughout the study period until 10 years

• Incidence of hospitalization for stroke

  Incidence of hospitalization for stroke during follow-up

  throughout the study period until 10 years

• incidence of pacemaker implantation

  incidence during follow-up of need for pacemaker implantation

  throughout the study period until 10 years

• incidence of pacemaker implantation of defibrillator

  incidence during follow-up of need for defibrillator implantation

  throughout the study period until 10 years

• Incidence of cardiac transplantation

  incidence during follow-up of need for cardiac transplantation

  throughout the study period until 10 years

• Incidence of transplantation of other solid organs

  incidence during follow-up of need for other solid organ transplantation

  throughout the study period until 10 years

• Mortality

  total mortality during follow up

  throughout the study period until 10 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all adult patients referred to the participating centers with a diagnosis of amyloidosis or carriers of pathogenic mutations starting from 01/01/1981 diagnosed in accordance with current international guidelines.

You may qualify if:

• 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

You may not qualify if:

• nothing

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Cardiomyopathies; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Simone Longhi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

simone longhi, MD

CONTACT

00390512149039; simone.longhi@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: March 10, 2025
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2033
• Study Completion (Estimated): August 31, 2033
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)