ATTRACT-52: Primary Care Cardiac Amyloidosis Screening in Ordu, Turkey
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Amyloidosis, Transthyretin Amyloidosis. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ATTRACT-52: Advancing TTR Testing and Risk-Based Amyloidosis Cardiac Screening in Primary Care - The Ordu Pilot Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL) [Time frame: Baseline (Day 0)]
Secondary outcome measures (3)
- Confirmed cardiac amyloidosis diagnosis rate [Time frame: Up to 12 months]
- Time from screening to confirmed diagnosis [Time frame: Up to 12 months]
- Feasibility and physician protocol adherence [Time frame: Up to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ordu University Faculty of Medicine, Department of Cardiology — Ordu
Identifiers
NCT: NCT07238426 · KAHSED-001 · KAHSED-001 · pending