ClinicalTrials.gov record NCT07238426
ATTRACT-52: Primary Care Cardiac Amyloidosis Screening in Ordu, Turkey
ATTRACT-52: Advancing TTR Testing and Risk-Based Amyloidosis Cardiac Screening in Primary Care - The Ordu Pilot Study
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.
This prospective, observational screening study pilots a risk-based pathway for transthyretin cardiac amyloidosis in primary care. Adults aged 65+ with cardiac or extracardiac 'red flags' are reviewed; patients judged high-suspicion receive NT‑proBNP/BNP testing in primary care before referral for standard confirmatory tests. The study measures diagnostic yield and the feasibility of this first-line screening model in family medicine centers.
What it is studying. Whether a risk-based screening pathway in primary care—using clinical red flags followed by NT‑proBNP/BNP testing when suspicion is high—can identify people at higher risk of transthyretin cardiac amyloidosis and how feasible that pathway is in family medicine settings.
What the researchers hope to learn. To measure the proportion of high-suspicion patients with elevated NT‑proBNP, the rate of confirmed ATTR-CM diagnoses among referred patients, time from screening to confirmed diagnosis, and the feasibility and clinician adherence to this primary-care screening pathway.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Cardiac amyloidosis is a progressive infiltrative cardiomyopathy, most commonly related to transthyretin (ATTR) misfolding. Although considered rare, emerging data suggest higher prevalence in specific regions, including the Black Sea area of Turkey. Early recognition improves outcomes. ATTRACT-52 is a prospective, observational, non-interventional screening study in primary care (family medicine centers) across Ordu province. Adults ≥65 years with cardiac or musculoskeletal "red flags" will be screened; those meeting high-suspicion criteria will undergo NT-proBNP/BNP testing at the primary care level to aid risk stratification prior to referral for confirmatory diagnostics.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age ≥65 years
- Registered patient in participating Family Medicine Centers (Ordu province)
- Cardiac history including at least one of: heart failure (I50), aortic stenosis (I35.0), cardiomyopathy (I42), atrioventricular block (I44), or atrial fibrillation (I48)
- Echocardiographic interventricular septal thickness ≥12 mm with preserved LVEF (≥50%), when available
- Ability to provide verbal or written consent
Exclusion criteria
- Known systemic AL amyloidosis
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Inability to provide consent
- Concurrent participation in an interventional trial
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
This study implements a risk-based screening pathway for suspected transthyretin cardiac amyloidosis (ATTR-CM) in primary care. Eligible adults (≥65 years) with relevant cardiac diagnoses (e.g., heart failure, aortic stenosis, cardiomyopathy, AV block, atrial fibrillation) and/or extracardiac red flags (e.g., carpal tunnel syndrome, spinal stenosis, trigger finger) will be reviewed against predefined criteria. When high suspicion is present, NT-proBNP (>600 pg/mL) or BNP (>150 pg/mL) will be obtained in primary care to refine risk prior to referral for confirmatory testing (e.g., bone scintigraphy, CMR) per standard care. Only high-risk patients will be tested; the number of tests will remain limited and appropriate for feasibility. Primary outcomes focus on diagnostic yield and feasibility of this first-line screening model in family medicine settings.
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.
Your primary-care clinician will check you against predefined cardiac and extracardiac red-flag criteria. If you meet high-suspicion criteria, a blood test for NT-proBNP (>600 pg/mL) or BNP (>150 pg/mL) will be done in primary care to refine risk. If results indicate high risk, you may be referred for confirmatory tests such as bone scintigraphy or cardiac MRI according to usual care. The study team will track diagnostic outcomes and feasibility (for example time to diagnosis) over follow-up (up to about 12 months).
How the study is structured. A prospective, observational (non-interventional) screening cohort conducted in primary care. Clinicians screen older adults for predefined cardiac and extracardiac 'red flags'; those judged high-suspicion have NT‑proBNP/BNP blood tests at the primary-care level and are referred for standard confirmatory diagnostics as indicated. Outcomes (diagnostic yield, time to diagnosis, and feasibility) are followed for up to 12 months.
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 registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in Turkey. 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.
Important dates
- Study start
- Dec 1, 2025
- Primary completion
- Oct 31, 2026 (estimated)
- Study completion
- Oct 31, 2026 (estimated)
- Target enrollment
- 800 participants (estimated)
- Last updated on registry
- Feb 25, 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
- Kotyora Family Medicine Health Management and Education Association
- Collaborators
- Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator)
- Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator)
Participating sites (1)
- Ordu University Faculty of Medicine, Department of Cardiology
Ordu, Ordu, 52200 · Turkey (Türkiye)
Terms used on this page · explanations by MedicalUpdates.ai
- eGFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- interventional
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- 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.
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