Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 6:43 AM
Study NCT ID:
NCT05452850
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2022-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis', 'timeFrame': 'Change from Baseline left and right ventricular global strain at 1 year', 'description': 'In this study, the effects of treatment strategies on left and right ventricular global and regional strain and its relationship with mortality and morbidity will be investigated in patients with AL-amyloidosis, who are still under treatment, and newly diagnosed with AL-amyloidosis.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging', 'timeFrame': 'Baseline, and 1st, 3rd, 6th, 12th Month follow-up', 'description': 'Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging was planned as a secondary objective.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac amyloidosis', 'Cardiomyopathy', 'Heart failure', 'Chemotherapy', 'Echocardiography', 'Strain imaging'], 'conditions': ['Amyloid Cardiomyopathy', 'Congestive Heart Failure', 'Chemotherapy Effect']}, 'referencesModule': {'references': [{'pmid': '27339491', 'type': 'RESULT', 'citation': 'Sperry BW, Ikram A, Hachamovitch R, Valent J, Vranian MN, Phelan D, Hanna M. Efficacy of Chemotherapy for Light-Chain Amyloidosis in Patients Presenting With Symptomatic Heart Failure. J Am Coll Cardiol. 2016 Jun 28;67(25):2941-8. doi: 10.1016/j.jacc.2016.03.593.'}, {'pmid': '34396169', 'type': 'RESULT', 'citation': 'Witteles RM, Liedtke M. AL Amyloidosis for the Cardiologist and Oncologist: Epidemiology, Diagnosis, and Management. JACC CardioOncol. 2019 Sep 24;1(1):117-130. doi: 10.1016/j.jaccao.2019.08.002. eCollection 2019 Sep.'}, {'pmid': '35811735', 'type': 'RESULT', 'citation': 'Bak M, Kim D, Choi JO, Kim K, Kim SJ, Jeon ES. Prognostic Implication of Longitudinal Changes of Left Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis. Front Cardiovasc Med. 2022 Jun 24;9:904878. doi: 10.3389/fcvm.2022.904878. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.', 'detailedDescription': 'Light chain amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods.\n\nAfter being informed about the study, it is planned to recruit and follow-up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18-90 years with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Patients who give the informed consent\n* Patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation\n\nExclusion Criteria:\n\n* A history of myocardial infarction, coronary artery disease, PCI and revascularization\n* \\< 18 years old\n* A history of severe aortic and mitral valve disease\n* Patients who do not give the informed consent\n* A history of severe hypertension (SBP\\>180 mmHg or DBP ≥110 mmHg or the need to use three or more antihypertensive agents)\n* Stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy)\n* Presence of non-amyloidosis, systemic, inflammatory or autoimmune disease\n* Patients whose cardiac imaging is not interpretable'}, 'identificationModule': {'nctId': 'NCT05452850', 'briefTitle': 'Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance', 'orgStudyIdInfo': {'id': '2021-53809'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Light Chain Cardiac Amyloidosis', 'description': 'Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant', 'interventionNames': ['Diagnostic Test: Left and Right Ventricular Global Strain Imaging']}], 'interventions': [{'name': 'Left and Right Ventricular Global Strain Imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['TomTec AutoStrain Suite Software', 'Philips Epiq CVx Echocardiography System', 'Philips X5-1 3D Echocardiography Probe'], 'description': 'Two-dimensional, color Doppler, spectral Doppler, and 3D digital echocardiographic image recordings will be taken from parasternal, apical, subcostal, and modified sections using a Philips Epiq CVx echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed with speckle tracking echocardiography from these recordings.', 'armGroupLabels': ['Light Chain Cardiac Amyloidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Burçak Kılıçkıran Avcı, Assoc Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University - Cerrahpasa'}, {'name': 'Deniz Mutlu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deniz Mutlu', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}