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Recruiting NCT06866912

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

Observational Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiomyopathy. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

observational epidemiological study of patients affected by systemic amyloidosis

Primary outcome measures

  • prevalence of amyloidosis [Time frame: throughout the study period until 10 years]
  • incidence of amyloidosis [Time frame: throughout the study period until 10 years]
  • Observational epidemiological study of patients with systemic amyloidosis [Time frame: throughout the study period until 10 years]
  • Types of cardiac clinical phenotype [Time frame: throughout the study period until 10 years]
  • Incidence of mixed clinical phenotype [Time frame: throughout the study period until 10 years]
  • Incidence of hospitalization for heart failure [Time frame: throughout the study period until 10 years]
  • Incidence of hospitalization for onset of arrhythmias [Time frame: throughout the study period until 10 years]
  • Incidence of hospitalization for stroke [Time frame: throughout the study period until 10 years]
  • incidence of pacemaker implantation [Time frame: throughout the study period until 10 years]
  • incidence of pacemaker implantation of defibrillator [Time frame: throughout the study period until 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06866912 · AMI-ER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗