Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 / or Hypomethylating Agent based regimens
Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
Patient provided written, informed consent.
Disqualifiers
Prior history of anthracycline or venetoclax_HMAs exposure.
Pre-existing severe structural heart disease (e.g., severe valvular heart disease, ischemic cardiomyopathy, basal LVEF <50%).
Persistent hemodynamically unstable arrhythmias.
Poor acoustic windows making reliable 2D-STE tracking impossible.
Trial population
* 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 / or Hypomethylating Agent based regimens * Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluation of cardiotoxcicity between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / 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 / 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
Time frame
2 yearsSecondary outcomes
1
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
Time frame
2 years2
Assesment of Organ Dysfunction
Measurement of CBC, Urea, Creatinine, AST, ALT, serum Albumin, Direct bilirubin and Total bilirubin
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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