Extracellular vesicles: where the amyloid precursor protein carboxyl-terminal fragments accumulate and amyloid-β oligomerizes.
Rocío Pérez-González, Yohan Kim, Chelsea Miller...
https://pubmed.ncbi.nlm.nih.gov/32772431Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID07314268
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
30 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
Researchers are investigating whether tiny particles called extracellular vesicles (EVs), released into the bloodstream by cells, can be used as early and less invasive markers for transthyretin amyloid cardiomyopathy (ATTR-CM). This condition often goes undiagnosed until significant heart damage occurs, so finding early detection methods is important. The study includes individuals with different forms of transthyretin amyloidosis and healthy controls to better understand disease stages. The study will enroll 70 adults divided into four groups: those with ATTR-CM and heart dysfunction, hereditary ATTR with mainly neurological symptoms, people with the gene but no symptoms, and healthy volunteers. All participants will provide blood samples for EV analysis. Those with heart involvement will also have cardiac imaging tests like echocardiography, cardiac MRI, and scintigraphy when needed to assess heart function and disease extent. Participants will undergo clinical evaluations, blood tests, imaging, and functional assessments to compare EV profiles with heart health and disease progression. The main measurements focus on EV concentration and protein profiles in the blood at the start. Researchers will look for links between EV characteristics and imaging results to see if EVs can help improve diagnosis and track changes in ATTR amyloidosis over time.
CONDITIONS
Brief 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
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of transthyretin cardiac amyloidosis with or without heart dysfunction
- Willingness to comply with study procedures
- Ability to provide written informed consent
You will not qualify if you...
- Presence of other significant heart conditions such as severe coronary artery disease or major valvular disease
- Inability to provide informed consent or participate in clinical assessments and examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Single time point at baseline
Participants undergo blood collection for extracellular vesicle isolation and molecular profiling. Those with cardiac involvement receive cardiac evaluations including echocardiography, cardiac MRI, and nuclear imaging when indicated.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to several years until study completion
Participants are observed to assess disease progression and correlate extracellular vesicle characteristics with clinical and imaging findings across different phenotypes and disease stages.
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
C
Camila R Moreno, PhD
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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https://pubmed.ncbi.nlm.nih.gov/27491882Nonbiopsy Diagnosis of Cardiac Transthyretin Amyloidosis.
Julian D Gillmore, Mathew S Maurer, Rodney H Falk...
https://pubmed.ncbi.nlm.nih.gov/27143678