Primary Amyloidosis Clinical Trials

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ATTR Amyloid Cardiomyopathy: Characterization of Extracellular Vesicles as Potential Disease Stratifiers and Prognostic Biomarkers

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study explores whether extracellular vesicles (EVs) tiny particles released into the bloodstream by cells can serve as early and minimally invasive biomarkers for transthyretin amyloid cardiomyopathy (ATTR-CM). Because ATTR-CM is often diagnosed only after significant heart damage has occurred, there is an urgent need for earlier detection methods. The study will enroll individuals with different clinical presentations of transthyretin amyloidosis, along with healthy controls. Participants will undergo blood sampling, cardiac imaging (including echocardiography, cardiac MRI, and scintigraphy when indicated), and molecular EV analysis. By comparing EV profiles across groups, the study aims to determine whether these vesicles reflect early cardiac involvement, track disease progression, and support more accurate and timely diagnosis. Ultimately, this research seeks to improve clinical decision-making and patient outcomes in ATTR cardiomyopathy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adult patients aged 18 years or older;

• Confirmed diagnosis of transthyretin cardiac amyloidosis (TTR-CA), with or without myocardial dysfunction, according to established diagnostic criteria;

• Willingness to comply with study procedures and requirements;

• Ability to provide written informed consent.

Locations
Other Locations
Brazil
Instituto do Coracao, HCFMUSP
RECRUITING
São Paulo
Contact Information
Primary
Felix Jose A Ramires, MD, PhD
felix.ramires@incor.usp.br
+551126615057
Backup
Camila R Moreno, PhD
camila.moreno@hc.fm.usp.br
551126615201
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 70
Treatments
TTR-CA + DM
TTR amyloid cardiomyopathy and myocardial dysfunction
TTR-A
TTR amyloidosis and neurological involvement
TTR-Gen
TTR amyloid genotype without phenotypic expression
CTL
healthy controls
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: InCor Heart Institute

This content was sourced from clinicaltrials.gov