Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT06201832
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Amyloidosis in HFpEF Tunisian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-14', 'studyFirstSubmitDate': '2023-12-02', 'studyFirstSubmitQcDate': '2023-12-31', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients', 'timeFrame': 'one year', 'description': 'Prevalence of cardiac amyloidosis in a Tunisian cohort of HFpEF patients aged 60 years or older with interventricular septal thickness equal to or greater than 12 mm'}], 'secondaryOutcomes': [{'measure': 'Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography', 'timeFrame': 'one year', 'description': 'Number of cardiac amyloidosis patients with impaired global longitudinal left ventricular strain and/or impaired left atrial strain on echocardiography and/or elevated extra cellular volume (ECV) on CMR.'}, {'measure': 'Frequency of different types of cardiac amyloidosis', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Amyloidosis', 'Heart Failure With Preserved Ejection Fraction', 'Echocardiography', 'CMR', 'Bone Scintigraphy', 'Prevalence', 'Diagnosis']}, 'descriptionModule': {'briefSummary': 'Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations.\n\nRegardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis.\n\nIn this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 60 years or older, admitted to hospital for HFpEF in the preceding year, and with an IVS thickness of 12 mm or greater.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HFpEF during the previous year\n* IVS thickness of 12mm or greater\n\nExclusion Criteria:\n\n* age under 60 years\n* Acute coronary syndrome complicated by HFpEF\n* Congenital heart disease'}, 'identificationModule': {'nctId': 'NCT06201832', 'acronym': 'Amy-Card', 'briefTitle': 'Cardiac Amyloidosis in HFpEF Tunisian Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia', 'orgStudyIdInfo': {'id': '13-2023'}}, 'contactsLocationsModule': {'locations': [{'zip': '2070', 'city': 'La Marsa', 'state': 'Tunis Governorate', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Lilia Zakhama, Prof', 'role': 'CONTACT', 'email': 'lilia.zakhama@fmt.utm.tn', 'phone': '98345427', 'phoneExt': '+216'}], 'facility': 'Security Hospital Forces', 'geoPoint': {'lat': 36.87818, 'lon': 10.32466}}], 'centralContacts': [{'name': 'Lilia Zakhama, Prof', 'role': 'CONTACT', 'email': 'lilia.zakhama@fmt.utm.tn', 'phone': '98345427', 'phoneExt': '+216'}], 'overallOfficials': [{'name': 'Lilia Zakhama, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lilia Zakhama', 'investigatorAffiliation': 'University Tunis El Manar'}}}}