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Enrolling by Invitation

NCT Number: NCT07238426

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL)

    Time frame: Baseline (Day 0)

    Percentage of high-suspicion cases exceeding the predefined NT-proBNP threshold at baseline.

Secondary outcomes

  1. Confirmed cardiac amyloidosis diagnosis rate

    Time frame: Up to 12 months

    Number and proportion of referred participants with confirmed ATTR-CM by standard diagnostics.

  2. Time from screening to confirmed diagnosis

    Time frame: Up to 12 months

    Interval (days) between initial screening and definitive diagnostic confirmation.

  3. Feasibility and physician protocol adherence

    Time frame: Up to 12 months

    Proportion of participating primary care physicians completing all required screening steps.

Sponsors and collaborators

Lead sponsor

Kotyora Family Medicine Health Management and Education Association

Network

Collaborators

  • Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator)
  • Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator)

Registry information

Official study title

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

Acronym: ATTRACT-52

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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