ATTRACT-52: Primary Care Cardiac Amyloidosis Screening in Ordu, Turkey

Kotyora Family Medicine Health Management and Education Association

Status: Not yet enrolling

Conditions: Transthyretin Amyloidosis; Cardiac Amyloidosis

Study type: Observational

Funder types: NETWORK; Other

Identifiers

NCT07238426

KAHSED-001 (Other Identifier)

pending (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

Risk-based Screening Cohort

Description:

Adults ≥65 years in primary care screened using predefined red flags; high-suspicion cases receive NT-proBNP/BNP testing before referral per standard care.