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Search / Trial NCT05703126

Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML

Launched by SAMARA STATE MEDICAL UNIVERSITY · Jan 26, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Acute Myeloid Leukemia Cardiotoxicity Endothelial Dysfunction Polychemotherapy Anthracyclines

ClinConnect Summary

This clinical trial is investigating how to better detect heart problems in patients with acute myeloid leukemia (AML) who are receiving a specific type of chemotherapy called anthracyclines. These medications, while effective for treating AML, can sometimes harm the heart, leading to serious complications. The researchers aim to find early signs of heart issues by using advanced tests that measure blood flow and heart function. By doing so, they hope to develop a method that helps doctors identify and treat heart problems sooner, which is crucial for improving patient care.

To participate in this study, you need to be between 18 and 65 years old, diagnosed with AML, and starting chemotherapy that includes anthracyclines. It's important that you do not have any current signs of heart failure and have a certain level of heart function before starting treatment. If you join the study, you can expect to undergo various tests that will help assess your heart and blood vessel health throughout your chemotherapy. The goal is to keep a close eye on your heart to manage any risks effectively while you receive your cancer treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients with acute myeloid leukemia receiving anthracycline-containing polychemotherapy regimens aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before starting chemotherapy;
  • availability of informed consent of the patient to participate in the study.
  • Exclusion Criteria:
  • acute violation of cerebral circulation in history;
  • a history of myocardial infarction;
  • the presence of diabetes mellitus type I and II;
  • the presence of chronic kidney disease C1-C5 stages;
  • the presence of stable angina III-IV functional classes;
  • the presence of unstable angina pectoris;
  • the presence of atrial fibrillation and flutter;
  • the presence of arterial hypertension of 2-3 degrees;
  • the presence of other oncological diseases;
  • inflammatory diseases in the acute stage;
  • diseases of the thyroid gland;
  • therapy with any monoclonal antibodies in history;
  • a positive test for the presence of HIV and hepatitis B and C;
  • alcoholism, drug addiction;
  • the presence of neuroleukemia, extramedullary foci of leukemia;
  • refusal of the patient to be examined.
  • the emergence of life-threatening situations during the study;
  • development in patients of diseases related to the non-inclusion criteria;
  • refusal of the patient to further examination.

About Samara State Medical University

Samara State Medical University is a distinguished institution dedicated to advancing medical education, research, and healthcare innovation. With a commitment to excellence, the university plays a pivotal role in clinical research, fostering collaborations that enhance patient care and contribute to the scientific community. Its state-of-the-art facilities and a team of experienced professionals ensure the highest standards in clinical trial management and execution, making it a trusted sponsor for studies aimed at improving health outcomes and addressing pressing medical challenges.

Locations

Samara, Samara Region, Russian Federation

Patients applied

0 patients applied

Trial Officials

Igor Davydkin

Principal Investigator

Samara State Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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