Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients

NCT07851012 | Not Yet Recruiting

• 1 other identifier: 04-2026-100534
• Study Type: observational
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Newly Diagnosed Acute Myeloid Leukemia (AML)

Outcome Measures

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

  2 years

Secondary Outcomes (2)

• Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups.

  2 years

• Assesment of Organ Dysfunction

  2 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Mohamed Fawzy Hussein, Assistant Lecturer

CONTACT

+201153375657; mo.fa@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Critical Care Unit ,Internal Medicine Department

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 14, 2026
• Primary Completion (Estimated): October 14, 2027
• Study Completion (Estimated): October 14, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share