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

NCT07238426 | Enrolling By Invitation

• 2 other identifiers: KAHSED-001pending
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transthyretin Amyloidosis; Cardiac Amyloidosis

Keywords

ATTR-CM; primary care; family medicine; NT-proBNP; HFpEF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Confirmed cardiac amyloidosis diagnosis rate

  Up to 12 months

• Time from screening to confirmed diagnosis

  Up to 12 months

• Feasibility and physician protocol adherence

  Up to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Known systemic AL amyloidosis
• Severe renal impairment (eGFR \<30 mL/min/1.73m²)
• Inability to provide consent
• Concurrent participation in an interventional trial

Sponsors & Collaborators

• Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator): collaborator
• Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator): collaborator
• Kotyora Family Medicine Health Management and Education Association: lead

Study Sites (1)

Ordu University Faculty of Medicine, Department of Cardiology

Ordu, Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Amyloidosis, Hereditary, Transthyretin-Related

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Seçkin Dereli, MD, Assoc. Prof.

  Ordu University Faculty of Medicine, Department of Cardiology (Turkey)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)