Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT06291805
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phenotyping and Characterization of wtATTR-CM (TRACE 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C567782', 'term': 'Amyloidosis, Hereditary, Transthyretin-Related'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blod and endomyocardial biopsies. No DNA test are made.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy.', 'timeFrame': 'Through study completion, 2 years.', 'description': 'Amyloid severity will be addressed using primarily NAC-stages and NYHA-class. Furthermore, we will use NT-pro-BNP, findings on echo (stroke volume, ejectionfraction and global longitudional strain) and finding on CMRI (LV mass, T1 myocardial values and extracellular volume).'}, {'measure': 'Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy.', 'timeFrame': 'Through study completion, 2 years.', 'description': 'Quality of life will be addressed using KCCQ summary score, EQ-5D Utility score and VAS ranging score and ATTR-QOL total score.'}, {'measure': 'Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy', 'timeFrame': 'Through study completion, 2 years.', 'description': 'Transthyretin (TTR) will be measured as follows: total TTR, misfolded TTR and fragmented TTR in plasma and misfolded TTR and fragmented TTR in urine.'}], 'secondaryOutcomes': [{'measure': 'Validation of a new amyloid specific questionnaire (ATTR-QoL) in comparison with Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Through study completion, 2 years.', 'description': 'Comparing ATTR-QOL total score to KCCQ summary score and EQ-5D Utility score and VAS ranging score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transthyretin Amyloidosis', 'Transthyretin Amyloid Cardiomyopathy', 'Wild-Type Transthyretin-Related (ATTR)Amyloidosis', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'Hypothesis:\n\n1. 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.\n2. 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.\n\nMethod:\n\nATTRwt-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.\n\nControl patients:\n\nA control cohort of 20 age- and gender-matched heart-healthy patients will be included for comparison of total/mis-/fragTTR values.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Including variating severity of wtATTR-CM by including 40 patients with NAC stage 1, 40 patients with NAC stage 2, and 20 patients with NAC stage 3. Furthermore, including a healthy control group in order to examine normal values of mis- and frag-TTR', 'healthyVolunteers': True, 'eligibilityCriteria': 'Group 1: wtATTR-CM patients\n\nInclusion Criteria:\n\n* Patients \\> 18 years diagnosed with ATTRwt-CM by:\n* endomyocardial biopsy\n* DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing.\n* Informed oral and written consent\n\nExclusion Criteria:\n\n* AL amyloidosis (light-chain amyloidosis).\n* Myelomatosis\n* Waldenström macroglobulinemia\n\nGroup 2: Control group\n\nInclusion Criteria:\n\n* Patients \\> 18 years\n* Informed oral and written consent\n\nExclusion Criteria:\n\n* Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension. Well-controlled hypertension is acceptable.\n* Suspicion of cardiac amyloidosis assessed through clinical history, physical examination, ECG, and echocardiography focusing on "red flags":\n* Echocardiography with:\n* Myocardial hypertrophy (septum \\>11 mm)\n* Apical sparing in LV-GLS\n* Infiltrative changes in the right ventricle free wall, thickened atrioventricular valves, or thickened atrial septum\n* Symptoms of polyneuropathy\n* Low voltage on ECG or discrepancy between left ventricular thickness and ECG amplitude indicative of low voltage\n* Atrioventricular block (AV block)\n* Bilateral carpal tunnel syndrome\n* Surgery for spinal stenosis\n* Elevated troponin I or NT-pro-BNP'}, 'identificationModule': {'nctId': 'NCT06291805', 'briefTitle': 'Phenotyping and Characterization of wtATTR-CM (TRACE 1)', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study', 'orgStudyIdInfo': {'id': '1-10-72-189-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'wtATTR-CM patients (n = 100)', 'description': '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)).\n\nSubgroup with these patient (n = 10): A endomyocardial biopsy.'}, {'label': 'Control (n = 20)', 'description': 'Blood and urine samples. To rule out cardiac disease: clinical history, physical examination, ECG and advanced echocardiography.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Arrhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sie Kronborg Fensman', 'role': 'CONTACT', 'email': 'siefensman@gmail.com', 'phone': '+45 30 48 88 85'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Sie Kronborg Fensman, MD', 'role': 'CONTACT', 'email': 'siefensman@gmail.com', 'phone': '+45 30 48 88 85'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steen Hvitfeldt Poulsen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc.', 'investigatorFullName': 'Steen Hvitfeldt Poulsen', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}