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NCT Number: NCT06866912

Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis

observational epidemiological study of patients affected by systemic amyloidosis

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Simone longhi, MD

CONTACT

[email protected]

00390512149039

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. prevalence of amyloidosis

    Time frame: throughout the study period until 10 years

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

  2. incidence of amyloidosis

    Time frame: throughout the study period until 10 years

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

  3. Observational epidemiological study of patients with systemic amyloidosis

    Time frame: throughout the study period until 10 years

    characteristics of each etiology in terms of baseline clinical data

  4. Types of cardiac clinical phenotype

    Time frame: throughout the study period until 10 years

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

  5. Incidence of mixed clinical phenotype

    Time frame: throughout the study period until 10 years

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

  6. Incidence of hospitalization for heart failure

    Time frame: throughout the study period until 10 years

    Incidence during follow-up of hospitalization for heart failure

  7. Incidence of hospitalization for onset of arrhythmias

    Time frame: throughout the study period until 10 years

    Incidence during follow-up of hospitalization for onset of arrhythmias

  8. Incidence of hospitalization for stroke

    Time frame: throughout the study period until 10 years

    Incidence of hospitalization for stroke during follow-up

  9. incidence of pacemaker implantation

    Time frame: throughout the study period until 10 years

    incidence during follow-up of need for pacemaker implantation

  10. incidence of pacemaker implantation of defibrillator

    Time frame: throughout the study period until 10 years

    incidence during follow-up of need for defibrillator implantation

  11. Incidence of cardiac transplantation

    Time frame: throughout the study period until 10 years

    incidence during follow-up of need for cardiac transplantation

  12. Incidence of transplantation of other solid organs

    Time frame: throughout the study period until 10 years

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

  13. Mortality

    Time frame: throughout the study period until 10 years

    total mortality during follow up

Study contacts

Contact information is provided by the study sponsor or research team.

simone longhi, MD

CONTACT

[email protected]

00390512149039

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: AMI-ER

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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