Clinical Trials in Denmark / NCT06291805
Recruiting
Observational
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
NCT06291805 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Transthyretin AmyloidosisTransthyretin Amyloid CardiomyopathyWild-Type Transthyretin-Related (ATTR)AmyloidosisQuality of Life
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. — Through study completion, 2 years.
Amyloid severity will be addressed using primarily NAC-stages and NYHA-class. Furthermore, we will use NT-pro-BNP, findings on echo (stroke volume, ejectionfraction and global longitudional strain) and finding on CMRI (LV mass, T1 myocardial values and extracellular volume). - Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. — Through study completion, 2 years.
Quality of life will be addressed using KCCQ summary score, EQ-5D Utility score and VAS ranging score and ATTR-QOL total score. - Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy — Through study completion, 2 years.
Transthyretin (TTR) will be measured as follows: total TTR, misfolded TTR and fragmented TTR in plasma and misfolded TTR and fragmented TTR in urine.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Aarhus University Hospital | Aarhus | Arrhus N | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06291805 on ClinicalTrials.gov ↗ ← All trials in Denmark