NCT07314268 ATTR Amyloid Cardiomyopathy: Characterization of Extracellular Vesicles as Potential Disease Stratifiers and Prognostic Biomarkers
| NCT ID | NCT07314268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Wild-type ATTR Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2024-10-18 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07314268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wild-type ATTR Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314268 currently recruiting?
Yes, NCT07314268 is actively recruiting participants. Contact the research team at felix.ramires@incor.usp.br for enrollment information.
Where is the NCT07314268 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07314268 clinical trial?
NCT07314268 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 70 participants.