ClinicalTrials.gov record NCT07314268

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationBrazil
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A prospective observational study enrolling about 70 adults across four groups: people with transthyretin (TTR) amyloidosis with heart involvement, hereditary TTR with mainly neurologic involvement, genotype-positive people without symptoms, and healthy controls. The study collects blood for extracellular vesicle (EV) analysis and links EV profiles with clinical data and cardiac imaging. Cardiac evaluations (echo, cardiac MRI, and scintigraphy when indicated) are done for those with cardiac involvement. Target follow-up is 12 months.

What it is studying. The study is testing whether characteristics of extracellular vesicles (tiny particles in blood) — their number and protein/molecular profiles — differ between ATTR groups and healthy controls and whether these EV features are associated with heart imaging findings and disease stage.

What the researchers hope to learn. To identify and quantify circulating extracellular vesicle features and protein signatures in people with different ATTR presentations; to correlate EV measures with echocardiography, cardiac MRI, and scintigraphy findings; and to generate data that may inform future diagnostic or disease‑stratification tools for ATTR amyloidosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive infiltrative disease caused by the deposition of misfolded transthyretin protein in the myocardium. Despite advances in imaging and treatment, early detection and accurate risk stratification remain major challenges, often resulting in delayed diagnosis and worse clinical outcomes. This prospective observational study will enroll 70 adult participants, distributed into four predefined groups:

  • ATTR-CM with myocardial dysfunction (n = 20)
  • Hereditary ATTR with predominant neurologic involvement (n = 20)
  • Genotype-positive individuals without clinical manifestation (n = 10)
  • Healthy controls (n = 20)

All participants will undergo blood collection for extracellular vesicle (EV) isolation and molecular profiling. EVs are nanoscale particles released by cells that carry proteins, lipids, and nucleic acids reflective of their cellular origin and physiological state, potentially serving as minimally invasive biomarkers. Participants with cardiac involvement will additionally undergo standardized cardiac evaluations, including echocardiography, cardiac MRI, and nuclear imaging when indicated. Clinical data, functional status, and laboratory parameters will be correlated with EV characteristics to assess their association with disease severity and progression. By integrating EV profiling with clinical and imaging findings across different phenotypes and disease stages, this study aims to identify biomarkers capable of improving diagnostic accuracy, tracking disease evolution, and supporting personalized care strategies in ATTR amyloidosis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give blood samples for isolation and molecular profiling of extracellular vesicles. Those with cardiac involvement will also undergo heart tests such as transthoracic echocardiography, cardiac MRI, and bone scintigraphy when indicated. Clinical information, functional status and routine laboratory data will be recorded and compared with EV findings. The study is prospective with about 12 months of follow-up and requires attending study visits and consenting to the procedures described.

How the study is structured. This is a prospective, observational cohort study lasting about 12 months. About 70 adult participants are enrolled into four predefined groups (cardiac ATTR with myocardial dysfunction; hereditary ATTR with neurologic involvement; genotype-positive without symptoms; healthy controls). Participants give blood for EV isolation and molecular profiling. Those with suspected or confirmed cardiac involvement also have standard cardiac tests (echocardiography, cardiac MRI, and nuclear scintigraphy when indicated). No treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Brazil. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 18, 2024
Primary completion
May 31, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
70 participants (estimated)
Last updated on registry
Jan 2, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Sao Paulo General Hospital
Principal investigator
FELIX JOSÉ ALVAREZ RAMIRES, Principal Investigator
University of Sao Paulo General Hospital
Collaborators
  • InCor Heart Institute

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Instituto do Coracao, HCFMUSPRecruiting

    São Paulo, São Paulo, 05403000 · Brazil

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials