Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT06261216
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '40mL of blood in aliquots at -80°C'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between lifetime physical activity (in METs) and disease development', 'timeFrame': '3rd to 6th decade', 'description': 'Association between lifetime physical activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy'}], 'secondaryOutcomes': [{'measure': 'Association between lifetime athletic activity (in METs) and disease development', 'timeFrame': '3rd to 6th decade', 'description': 'Association between lifetime athletic activity (in METs per active decade) and the development of wild-type transthyretin amyloid cardiomyopathy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyloid Cardiomyopathy', 'Wild Type ATTR Amyloidosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy.', 'detailedDescription': 'Transthyretin amyloidosis is considered to be the most common cause of cardiac amyloidosis, with an increasing diagnosis rate over the last decade. Though once considered to be a rare disease, recent data suggest it is underappreciated as a common cause of cardiac diseases and syndromes such as left ventricular hypertrophy, aortic stenosis, and heart failure with preserved ejection fraction, especially in the elderly. Wild-type transthyretin amyloidosis, which is associated with ageing, is currently considered to be the most frequent form of amyloidosis worldwide, and is dominated by cardiac symptoms. Other than male gender and advanced age, risk factors for the development of wild-type transthyretin amyloid cardiomyopathy (wtATTR-CM) are largely unknown. There is rising empirical observation that patients with wtATTR-CM frequently have a substantial history of athletic activity, which might contribute to the manifestation of the disease.\n\nThis study aims to create evidence of a correlation between increased lifetime physical activity and the development of wtATTR-CM. Furthermore, the investigators aim to explore the association between certain sport disciplines and disease development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Number of participants: 189 The study population will comprise three subgroups (n=63 in each group)\n\n1. cardiac wild type transthyretin amyloidosis (wtATTR-CM);\n2. heart failure (HF);\n3. healthy individuals without heart disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of wtATTR-CM including sequencing of the TTR gene; or HF; or healthy proband without a diagnosis of heart disease\n2. Initial diagnosis of respective cardiac disease (wtATTR-CM, HF) after the 6th decade of life; or no cardiac disease (healthy control)\n3. Willingness and ability to provide signed informed consent form (ICF)\n4. Age \\> 60 years\n\nExclusion Criteria:\n\n1. History of severe chronic illness limiting the ability to perform physical activity during the 3rd to 6th decade\n2. A diagnosis of dementia or cognitive impairment\n3. Any other reason resulting in the inability to perform the questionnaire and/or interview\n4. Known disease-causing variant (pathogenic or likely-pathogenic) in the TTR gene'}, 'identificationModule': {'nctId': 'NCT06261216', 'briefTitle': 'Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy', 'orgStudyIdInfo': {'id': '01/2023/LPA-wtATTR/NVNS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'wild-type transthyretin amyloid cardiomyopathy', 'interventionNames': ['Other: Interview']}, {'label': 'heart failure', 'interventionNames': ['Other: Interview']}, {'label': 'healthy controls', 'interventionNames': ['Other: Interview']}], 'interventions': [{'name': 'Interview', 'type': 'OTHER', 'description': '* International Physical Activity Questionnaire (IPAQ-SF)\n* interviewer-administered modified Lifetime Total Physical Activity Questionnaire (LTPAQ) form', 'armGroupLabels': ['healthy controls', 'heart failure', 'wild-type transthyretin amyloid cardiomyopathy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'PI', 'role': 'CONTACT', 'email': 'nicolas.verheyen@medunigraz.at', 'phone': '0043 316 385 30173'}, {'name': 'Nicolas Verheyen, Res Prof, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nora Schwegel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Nicolas Verheyen, Res Prof, MD PhD', 'role': 'CONTACT', 'email': 'nicolas.verheyen@medunigraz.at', 'phone': '0043 316 385 30173'}, {'name': 'Nora Schwegel, MD', 'role': 'CONTACT', 'email': 'nora.schwegel@medunigraz.at', 'phone': '0043 316 385 31414'}], 'overallOfficials': [{'name': 'Nicolas Verheyen, Res Prof, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}