NCT06291805 Phenotyping and Characterization of wtATTR-CM (TRACE 1)
| NCT ID | NCT06291805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steen Hvitfeldt Poulsen |
| Condition | Transthyretin Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-02-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06291805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transthyretin Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06291805 currently recruiting?
Yes, NCT06291805 is actively recruiting participants. Contact the research team at siefensman@gmail.com for enrollment information.
Where is the NCT06291805 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06291805 clinical trial?
NCT06291805 is sponsored by Steen Hvitfeldt Poulsen. The trial plans to enroll 120 participants.