NCT06291805Recruiting
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 30 Jan 2024
- Start date
- 20 Feb 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Steen Hvitfeldt Poulsen
- Diseases
- Amyloidosis
- NCT number
- NCT06291805
What you commit to
- Study type: Observational
- Planned participants: 120
- From 20 Feb 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery for spinal stenosis
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- Group 1: wtATTR-CM patients
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.