Actively Recruiting
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Led by Steen Hvitfeldt Poulsen · Updated on 2025-08-15
120
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
Sponsors
S
Steen Hvitfeldt Poulsen
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years diagnosed with Wild-type Transthyretin Amyloidosis Cardiomyopathy (ATTRwt-CM) confirmed by endomyocardial biopsy or DPD scintigraphy with Perugini grade 2-3 and genetic testing excluding variant amyloidosis
- Informed oral and written consent for ATTRwt-CM patient group
- Patients older than 18 years for control group
- Informed oral and written consent for control group
You will not qualify if you...
- Light-chain amyloidosis (AL amyloidosis)
- Myelomatosis
- Waldenström macroglobulinemia
- Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension (well-controlled hypertension is allowed) for control group
- Suspicion of cardiac amyloidosis based on clinical history, physical exam, ECG, or echocardiography signs such as myocardial hypertrophy, apical sparing, infiltrative changes, thickened valves or septum, polyneuropathy symptoms, low ECG voltage, AV block, bilateral carpal tunnel syndrome, spinal stenosis surgery, or elevated troponin I or NT-pro-BNP for control group
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Arrhus N, Denmark, 8200
Actively Recruiting
Research Team
S
Sie Kronborg Fensman, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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