Phenotyping and Characterization of wtATTR-CM (TRACE 1)
NCT ID: NCT06291805
Last Updated: 2025-08-15
Study Results
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Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-02-20
2025-12-31
Brief Summary
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Detailed Description
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1. We hypothesize that more severe wild-type amyloidosis cardiomyopathy (ATTRwt-CM) according to clinical, biochemical, and diagnostic imaging parameters are correlated with worse quality of life (QoL) for patients.
2. We expect misfolded (misTTR) and/or fragmented transthyretin (fragTTR) to be measurable in plasma and/or urine and fragTTR to be detectable in endomyocardial biopsies from patients with ATTRwt-CM. We expect the values of misTTR and fragTTR to be correlated with the severity of ATTRwt-CM according to clinical, biochemical, and diagnostic imaging parameters. We expect the level of fragTTR from endomyocardial biopsies to be correlated with plasma levels of fragTTR.
Method:
ATTRwt-CM patients: Prospective inclusion of 100 consecutive ATTRwt-CM patients reflecting all NAC stages (40 patients from NAC disease stage 1, 40 patients from NAC disease stage II and 20 patients from NAC disease stage III). Patients will be recruited from the out-patient amyloidosis clinic at Aarhus University hospital. Patients will be thoroughly clinically assessed.
Control patients:
A control cohort of 20 age- and gender-matched heart-healthy patients will be included for comparison of total/mis-/fragTTR values.
The investigating into QoL, bio markers and the analyses on cardiac MR imaging markers will hopefully provide us with tools to evaluate and monitor disease progression and response to treatment.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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wtATTR-CM patients (n = 100)
Clinical history, physical examination, ECG, advanced echocardiography, blood and urine samples, cardiac magnetic resonance imaging (CMRI), and QoL questionaires (KCCQ, EQ-5Q-5L and ATTR-QoL)).
Subgroup with these patient (n = 10): A endomyocardial biopsy.
No interventions assigned to this group
Control (n = 20)
Blood and urine samples. To rule out cardiac disease: clinical history, physical examination, ECG and advanced echocardiography.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Myelomatosis
* Waldenström macroglobulinemia
Group 2: Control group
* 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
18 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Steen Hvitfeldt Poulsen
OTHER
Responsible Party
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Steen Hvitfeldt Poulsen
Professor, DMSc.
Locations
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Aarhus University Hospital
Aarhus, Arrhus N, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1-10-72-189-23
Identifier Type: -
Identifier Source: org_study_id
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