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Phenotyping and Characterization of wtATTR-CM (TRACE 1)

Recruitingn/aAges 18 Years - anyAllSteen Hvitfeldt Poulsen
NCT06291805 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.

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📋 Eligibility rules (as published)
Group 1: wtATTR-CM patients Inclusion Criteria: * Patients \> 18 years diagnosed with ATTRwt-CM by: * endomyocardial biopsy * DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing. * Informed oral and written consent Exclusion Criteria: * AL amyloidosis (light-chain amyloidosis). * Myelomatosis * Waldenström macroglobulinemia Group 2: Control group Inclusion Criteria: * Patients \> 18 years * Informed oral and written consent Exclusion Criteria: * Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension. Well-controlled hypertension is acceptable. * Suspicion of cardiac amyloidosis assessed through clinical history, physical examination, ECG, and echocardiography focusing on "red flags": * Echocardiography with: * Myocardial hypertrophy (septum \>11 mm) * Apical sparing in LV-GLS * Infiltrative changes in the right ventricle free wall, thickened atrioventricular valves, or thickened atrial septum * Symptoms of polyneuropathy * Low voltage on ECG or discrepancy between left ventricular thickness and ECG amplitude indicative of low voltage * Atrioventricular block (AV block) * Bilateral carpal tunnel syndrome * Surgery for spinal stenosis * Elevated troponin I or NT-pro-BNP
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What it tests

  • Not listed
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Where

1 site
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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