Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT03542058
Status:
UNKNOWN
Last Update Posted:
2018-05-31
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac function', 'timeFrame': '6 months', 'description': 'This will be measured by mean GLS(Global Longitudinal strain) value.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy Related Cardiac Dysfunction']}, 'descriptionModule': {'briefSummary': 'The objective of this research is to describe the burden of subclinical anthracycline therapy related cardiac dysfunction( ATRCD) by applying international guideline on Uganda cancer patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.', 'detailedDescription': "Specific objectives:\n\n1. To determine the incidence of subclinical ATRCD among cancer patient who receives Anthracycline therapy.\n2. To compare the changes of GLS value between hypertension and non hypertension cancer patient at the competition of the anthracycline therapy.\n3. To determine the correlation of conventional echocardiograghy(ECHO) parameters (MAPSE, S') with GLS, and their ability to diagnose or rule out subclinical ATRCD.\n4. To determine the correlation of oxidative stress with cardiac function(GLS value) in patients who receives Anthracycline therapy\n5. To describe the cardioprotective effect of carvedilol in patients with subclinical ATRCD.\n\nMETHODS This is going to be two prospective cohort study (cohort 1 and 2) followed by a randomized controlled trial (cohort 3).\n\nTo achieve objective 1 ,3 and 4, Cohort 1 will consecutively recruit 300 adult non hypertension cancer patients who are going to receive anthracycline therapy.\n\nTo achieve objective 2, Cohort 2 will consecutively recruit 53 adult hypertension cancer patients (group H) and 106 non hypertension controls (group N) who are going to receive anthracycline therapy. Controls will be recruited from cohort 1 by systemic sampling( Choosing the 2nd patients as they are enrolled in cohort 1).\n\nPatient's demographic data, cancer diagnosis, dosage of anthracyclin, past medical history, symptoms, physical examinations, ECG, ECHO and laboratory data will be collected at the baseline. Patient follow up will be performed at the completion of the chemo therapy, and 6month thereafter. Data of symptoms, physical examinations, ECG, ECHO and blood test will be collected at each visit. The end point will be the development of subclinical ATRCD.\n\nTo achieve objective 5, patients in Cohort 1, who are diagnosed with Subclinical ATRCD will be recruited into cohort 3 and being randomized into group T(carvedilol treatment group) and group C( control, none treatment group).Systemic randomization will be used in Cohort 3: ever second eligible patient will be recruited in group C. Patients in cohort 3 will be followed up for 6month."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between and include 18 and 50 years.\n2. Newly diagnosed cancer patients who develop subclinical ATRCD during cardiac follow up.\n\nExclusion Criteria:\n\n1. Patient who has been taking carvedilol prior to the study\n2. Patient who self report to be allergic to carvedilol\n3. Systolic blood pressure \\< 90mmHg\n4. Heart Rate \\< 50 beat per minute\n5. Patient who is asthmatic or has chronic obstructive lung disease\n6. Pregnant woman'}, 'identificationModule': {'nctId': 'NCT03542058', 'acronym': 'SATRACD', 'briefTitle': 'Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country', 'orgStudyIdInfo': {'id': 'Cardio-oncology study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Study participants will receive carvedilol for a period of 6 month. The initial dosage of carvedilol will be 3.125mg twice daily. Dosage will be titrated up two weekly until the maximum tolerable dose or ceiling dose of 25mg twice daily has been reached.', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Study participant will not receive any cardiac medication, apart from standard cancer care.'}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'otherNames': ['Carvedilol Denk'], 'description': 'Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wan Zhu Zhang, Master', 'role': 'CONTACT', 'email': 'raniox@hotmail.com', 'phone': '+256774431009'}, {'name': 'Emmy Okello, PhD', 'role': 'CONTACT', 'email': 'emmyoks@gmail.com', 'phone': '+775522284'}], 'overallOfficials': [{'name': 'Karen Sliwa, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hatter Institute for Cardiovascular Disease in Africa'}, {'name': 'Feriel Azibani, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hatter Institute for Cardiovascular Disease in Africa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cape Town', 'class': 'OTHER'}, {'name': 'Uganda Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}