Cardiac Amyloidosis, Transthyretin Amyloidosis
Conditions
Keywords
ATTR-CM, primary care, family medicine, NT-proBNP, HFpEF
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.
Interventions
None listed
Sponsors
Kotyora Family Medicine Health Management and Education Association
Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator)
Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of high-suspicion participants with elevated NT-proBNP (>600 pg/mL) | Baseline (Day 0) | Percentage of high-suspicion cases exceeding the predefined NT-proBNP threshold at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed cardiac amyloidosis diagnosis rate | Up to 12 months | Number and proportion of referred participants with confirmed ATTR-CM by standard diagnostics. |
| Time from screening to confirmed diagnosis | Up to 12 months | Interval (days) between initial screening and definitive diagnostic confirmation. |
| Feasibility and physician protocol adherence | Up to 12 months | Proportion of participating primary care physicians completing all required screening steps. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORSeçkin Dereli, MD, Assoc. Prof.
Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
Outcome results
None listed