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

ATTRACT-52: Advancing TTR Testing and Risk-Based Amyloidosis Cardiac Screening in Primary Care - The Ordu Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Transthyretin Amyloidosis; Cardiac Amyloidosis

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ordu
    • Ordu, Ordu, Turkey (Türkiye), 52200
      • Ordu University Faculty of Medicine, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged ≥65 years receiving care at Family Medicine Centers in Ordu province with cardiac and/or extracardiac red flags suggestive of possible ATTR-CM.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL)	Percentage of high-suspicion cases exceeding the predefined NT-proBNP threshold at baseline.	Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed cardiac amyloidosis diagnosis rate	Number and proportion of referred participants with confirmed ATTR-CM by standard diagnostics.	Up to 12 months
Time from screening to confirmed diagnosis	Interval (days) between initial screening and definitive diagnostic confirmation.	Up to 12 months
Feasibility and physician protocol adherence	Proportion of participating primary care physicians completing all required screening steps.	Up to 12 months

Collaborators and Investigators

• 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)
• Investigators: Principal Investigator: Seçkin Dereli, MD, Assoc. Prof., Ordu University Faculty of Medicine, Department of Cardiology (Turkey)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: primary care; family medicine; HFpEF; NT-proBNP; ATTR-CM
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Amyloid Neuropathies; Amyloidosis, Familial; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Amyloid Neuropathies, Familial; Amyloidosis, Hereditary, Transthyretin-Related
• Other Study ID Numbers: KAHSED-001 (Other Identifier: Kotyora Family Medicine Health Management and Education Association (KAHSED)); Pending (Clinical Research Information Service)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planned for this pilot observational screening study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No