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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Kotyora Family Medicine Health Management and Education Association · Network
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiac Amyloidosis
• Transthyretin Amyloidosis

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2025-11-20
• Last updated: 2026-02-25

Locations

1 site across 1 country: Turkey (Türkiye)