Using tiny blood particles to detect and track ATTR heart amyloidosis
Official title: ATTR Amyloid Cardiomyopathy: Characterization of Extracellular Vesicles as Potential Disease Stratifiers and Prognostic Biomarkers
Run by University of Sao Paulo General Hospital · NCT07314268 · Data updated 2026-11-12
This project will test whether tiny blood particles called extracellular vesicles can help detect and track transthyretin (ATTR) amyloid cardiomyopathy in people with or at risk for ATTR.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | October 18, 2024 |
| Main results expected | May 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07314268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (18+) with confirmed transthyretin cardiac amyloidosis, people with hereditary ATTR (predominantly neurologic), genotype-positive individuals without symptoms, and healthy volunteers willing to undergo blood draws and cardiac imaging as needed.
✕Probably not a fit
Patients with other major cardiac conditions (for example severe coronary artery disease or significant valvular disease) or those unable to attend imaging visits or provide informed consent are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study will enroll 70 adults divided into four groups: ATTR-CM with myocardial dysfunction, hereditary ATTR with mainly neurologic involvement, genotype-positive individuals without symptoms, and healthy controls. All participants will provide blood for isolation and molecular profiling of extracellular vesicles (EVs), and participants with cardiac involvement will receive standardized echocardiography, cardiac MRI, and nuclear imaging when indicated. Investigators will compare EV protein and molecular signatures with imaging findings, clinical status, and laboratory measures to determine whether EVs reflect early cardiac involvement or disease progression. The aim is to identify minimally invasive EV biomarkers to improve timely diagnosis and risk stratification in ATTR-CM.
Why it matters
Potential benefit: If successful, this could lead to a simple blood-based test that detects ATTR cardiac involvement earlier and helps guide treatment decisions.
How similar studies have gone: Early EV biomarker studies in other cardiac and systemic diseases have shown promise, but applying EV profiling specifically to ATTR-CM is relatively novel and not yet clinically validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Presence of other significant cardiac conditions that may interfere with study outcomes, such as severe coronary artery disease or major valvular disease; * Inability to provide informed consent or to participate in the required clinical assessments and examinations.
Where it's running
-
Instituto do Coracao, HCFMUSP
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Felix Jose A Ramires, MD, PhD
- Email: felix.ramires@incor.usp.br
- Phone: +551126615057
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.