Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05929209

Exploring Biomarkers in Hereditary Transthyretin Amyloidosis

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-09-24

80

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hereditary transthyretin amyloidosis (ATTRv, v for variant) is a severe and heterogeneous systemic condition due to mutations in the transthyretin (TTR) gene. The availability of disease-modifying therapies has led to an urgent need to have reliable biomarkers capable of assessing the clinical severity of the disease and of monitoring the efficacy of pharmacological treatment. At the same time, early markers for the clinical onset of ATTRv amyloidosis in presymptomatic subjects are needed to enable earlier initiation of anti-amyloid therapy. In this project the investigators seek to achieve three main goals: to identify and validate disease severity biomarkers in symptomatic patients; to establish disease onset biomarkers of ATTRv amyloidosis in presymptomatic subjects; to explore new pathogenetic mechanisms underlying this multisystem disorder, such as mitochondrial dysfunction and immune response.

CONDITIONS

Official Title

Exploring Biomarkers in Hereditary Transthyretin Amyloidosis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Molecularly defined patients with hereditary transthyretin amyloidosis, carrying TTR pathogenic variants
  • Presymptomatic carriers of the pathogenic variants in TTR gene
  • Subjects aged 18 years or older
  • Signed informed consent indicating understanding of the study
Not Eligible

You will not qualify if you...

  • Unable or unwilling to follow study requirements including visits and questionnaires
  • Unable to sign informed consent
  • Severe psychiatric diseases

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, ID, Italy, 00168

Actively Recruiting

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Research Team

G

Guido Alessandro Primiano

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Exploring Biomarkers in Hereditary Transthyretin Amyloidosis | DecenTrialz