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

NCT ID: NCT07238426

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-10-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator)

UNKNOWN

Sponsor Role: collaborator

Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator)

UNKNOWN

Sponsor Role: collaborator

Kotyora Family Medicine Health Management and Education Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seçkin Dereli, MD, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Seçkin Dereli, MD, Assoc. Prof.

Role: CONTACT

drseckindereli@gmail.com

+90 533 376 09 84

Bestegül Çoruh Akyol, MD, Asst. Prof.

Role: CONTACT

kahsedbilimseldestek@gmail.com

+90 532 584 99 38

Other Identifiers

KAHSED-001

Identifier Type: OTHER

Identifier Source: secondary_id

pending

Identifier Type: OTHER

Identifier Source: secondary_id

KAHSED-001

Identifier Type: -

Identifier Source: org_study_id