Studies quality of life and heart severity in wild-type transthyretin amyloid heart disease
Studies quality of life and heart disease severity in adults with amyloid heart disease.
Plain-language title generated from the registry record
Registry title: Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Key facts
- Where
- Aarhus, DenmarkSee the site
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steen Hvitfeldt Poulsen
- Trial code
- NCT06291805
- Record updated
- 15 August 2025
- Original description
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.Read full original descriptionShow less
Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study
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.
Inclusion: 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; Patients > 18 years; Informed oral and written consent.
Exclusion: Surgery for spinal stenosis; 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":; Myocardial hypertrophy (septum >11 mm); Bilateral carpal tunnel syndrome; AL amyloidosis (light-chain amyloidosis); Myelomatosis; Waldenström macroglobulinemia; Group 2: Control group; Echocardiography with:; 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); Elevated troponin I or NT-pro-BNP.
Group 1: wtATTR-CM patients.