Cardiac AmyloidosisATTRACT-52NCT07238426
ATTRACT-52: Primary Care Cardiac Amyloidosis Screening in Ordu, Turkey
An observational study of Cardiac Amyloidosis and Transthyretin Amyloidosis, run by Kotyora Family Medicine Health Management and Education Association at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Amyloidosis, Transthyretin Amyloidosis
- How many people
- 800 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 31 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Known systemic AL amyloidosis
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Inability to provide consent
- Concurrent participation in an interventional trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University Faculty of Medicine, Department of Cardiology
Ordu, Ordu, 52200
About this study
Official title: 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.
Read the 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
- Keywords
- ATTR-CM, primary care, family medicine, NT-proBNP, HFpEF
- Medical subject headings
- Amyloid Neuropathies, Familial, Amyloidosis, Hereditary, Transthyretin-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0)
Secondary outcomes (3)
Confirmed cardiac amyloidosis diagnosis rate
Number and proportion of referred participants with confirmed ATTR-CM by standard diagnostics.
Measured: Up to 12 months
Time from screening to confirmed diagnosis
Interval (days) between initial screening and definitive diagnostic confirmation.
Measured: Up to 12 months
Feasibility and physician protocol adherence
Proportion of participating primary care physicians completing all required screening steps.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kotyora Family Medicine Health Management and Education Association
- Sponsor type
- Research network
- Collaborators
- Ordu University, Faculty of Medicine - Department of Cardiology (Academic Collaborator), Ordu Provincial Health Directorate - Family Medicine Network (Regional Collaborator)
- Responsible party
- Sponsor
- Investigators
- Seçkin Dereli, MD, Assoc. Prof., Principal investigator, Ordu University Faculty of Medicine, Department of Cardiology (Turkey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238426
- Sponsor's protocol ID
- KAHSED-001
- Other IDs
- KAHSED-001, pending
- Acronym
- ATTRACT-52
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned for this pilot observational screening study.