[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658531":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":20,"interventions":20,"overallOfficials":20,"centralContacts":26,"locations":20,"responsibleParty":32,"collaborators":20,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":20,"briefSummary":50,"conditions":51,"keywords":20,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluation of cardiotoxcicity between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and \u002F or HMA regimens after four cycles of chemotherpy",".To evaluate and compare the incidence of subclinical cardiotoxicity (defined as a relative reduction in Left Ventricular GLS \\>15 % from baseline) between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and \u002F or HMA regimens after four cycles of chemotherpy by speckle tracking echocardiographic assesment which measure Global longitudinal strain also by ECG,High sensitive Troponin and CKMb","2 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups.","Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups by measurement of Left ventricular ejection fraction by M-Mode",{"measure":18,"description":19,"timeFrame":12},"Assesment of Organ Dysfunction","Measurement of CBC, Urea, Creatinine, AST, ALT, serum Albumin, Direct bilirubin and Total bilirubin",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","Acute Myeloid Leukemia (AML) is an aggressive hematologic malignancy that necessitates immediate risk assessment and therapeutic intervention.\n\nAcute myeloid leukemia (AML) is a rapidly progressing myeloid neoplasm characterized by the clonal expansion of immature myeloid-derived cells, known as blasts, in the peripheral blood and bone marrow. This expansion results in ineffective erythropoiesis and megakaryopoiesis, clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This leads to inadequate production of red blood cells and platelets.\n\nAlthough the administration of multiagent induction chemotherapy can induce complete remission, allogeneic stem cell transplantation is the only established curative therapy. Despite advancements in therapeutic approaches, prognosis remains suboptimal, especially among the older populations.\n\nIntensive induction chemotherapy containing cytarabine and an anthracycline has been part of the upfront and salvage treatment of AML for decades. Unfortunately, anthracyclines are considered the principal culprit drugs behind chemotherapy-induced cardiotoxicity. Anthracycline-induced cardiotoxicity (AIC) is classified into acute and chronic based on the time of onset, with chronic cardiotoxicity potentially occurring within a year or several years after the completion of anthracycline treatment. The cardiotoxicity is almost exclusively chronic, and only a small proportion is acute and typically reversible upon discontinuation of anthracycline treatment.\n\nIn contrast, Venetoclax, a B-cell leukemia\u002Flymphoma-2 inhibitor, is a promising novel drug that is currently used with hypomethylating agents (HMAs) like Azacitidine or Decitabine in older patients with acute myeloid leukemia (AML). These patients are known to have a high burden of cardiovascular (CV) risk factors and comorbidities.\n\nThe toxicity profile of Venetoclax includes neutropenia, gastrointestinal issues, and diarrhea, while there is growing concern regarding its potential cardiotoxicity in patients undergoing treatment for Acute Myeloid Leukemia. High doses or prolonged use of Venetoclax may lead to serious cardiac complications, such as myocardial infarction, new-onset atrial fibrillation, and even sudden cardiac death.\n\nTraditionally, cardiotoxicity monitoring is conducted via serial measurements of Left Ventricular Ejection Fraction (LVEF) through standard echocardiography. However, LVEF is an insensitive and late indicator; a drop in LVEF occurs only after a significant loss of myocardial reserve has already taken place, often rendering the damage irreversible.Speckle Tracking Echocardiography (STE) is an advanced, non-invasive imaging modality that quantifies myocardial deformation by tracking acoustic markers (speckles) frame-by-frame. It measures Global Longitudinal Strain (GLS), which can detect subclinical cardiotoxicity (early micro-vascular and myofibrillar dysfunction) long before any detectable decline in conventional LVEF manifests.","* Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and \u002F or Hypomethylating Agent based regimens\n* Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Mohamed Fawzy Hussein, Assistant Lecturer","CONTACT","+201153375657","mo.fa@yahoo.com",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Mohamed Fawzy Hussein Mohamed","Assistant Lecturer at Critical Care Unit ,Internal Medicine Department","100658531","cardiotoxicity-in-newly-diagnosed-acute-myeloid-leukemia-patients-100658531",false,"NCT07851012","Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients","Assessment of Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients: Anthracycline-Based Induction Versus Venetoclax - Hypomethylating Agent RegimensJ","AML\u002FHMA","Inclusion Criteria:•\n\n* Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and \u002F or Hypomethylating Agent based regimens\n* Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.\n* Patient provided written, informed consent.\n\nExclusion Criteria:\n\n* Prior history of anthracycline or venetoclax\\_HMAs exposure.\n* Pre-existing severe structural heart disease (e.g., severe valvular heart disease, ischemic cardiomyopathy, basal LVEF \\\u003C50%).\n* Persistent hemodynamically unstable arrhythmias.\n* Poor acoustic windows making reliable 2D-STE tracking impossible.","ALL","16 Years",{"count":47,"type":48},146,"ESTIMATED","OBSERVATIONAL","The aim of this study is to evaluate and compare the cardiotoxic effects associated with anthracycline-based induction chemotherapy and those receiving a Venetoclax or HMA regimens after four cycles of chemotherpy in patients with newly diagnosed acute myeloid leukemia.",[52],"Newly Diagnosed Acute Myeloid Leukemia (AML)","NOT_YET_RECRUITING","2026-09-24",{"date":56,"type":57},"2026-10-01","ACTUAL",{"date":59,"type":48},"2026-10-14",{"date":61,"type":48},"2028-10-14",{"name":5,"class":6}]