Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07314268

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

Led by University of Sao Paulo General Hospital · Updated on 2026-01-02

70

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

Sponsors

U

University of Sao Paulo General Hospital

Lead Sponsor

I

InCor Heart Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Confirmed diagnosis of transthyretin cardiac amyloidosis (TTR-CA), with or without heart dysfunction, based on established criteria
  • Willingness to comply with study procedures and requirements
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Presence of other significant heart conditions that may affect study results, such as severe coronary artery disease or major valvular disease
  • Inability to provide informed consent or participate in required clinical assessments and exams

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto do Coracao, HCFMUSP

São Paulo, São Paulo, Brazil, 05403000

Actively Recruiting

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Research Team

F

Felix Jose A Ramires, MD, PhD

CONTACT

C

Camila R Moreno, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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