Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05703126

Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia

Led by Samara State Medical University · Updated on 2024-11-05

100

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute myeloid leukemia (AML) is a disease where immature blood cells grow uncontrollably due to a mutation. This condition is treated with anthracycline antibiotics, which have been used since the 1970s. However, these drugs can harm the heart, causing problems like heart failure and irregular heartbeats. This trial aims to improve early detection of heart and blood vessel problems related to chemotherapy in AML patients by using detailed tests and measurements. Participants will receive chemotherapy containing anthracyclines and cytarabine following a standard regimen. The study compares two groups of AML patients aged 18 to 65, all without signs of heart failure and with normal heart function initially. One group shows a decrease in heart muscle strain during treatment, while the control group does not. Various diagnostic tests, including laser Doppler flowmetry, stress echocardiography, blood tests for heart and vessel markers, and imaging scans, will be performed before and after each chemotherapy course. Participants will undergo multiple assessments such as history taking, body measurements, blood tests, heart imaging, and vessel scans throughout up to 10 months of chemotherapy treatment. The study will measure changes in heart muscle strain, microcirculation, and biochemical markers after each chemotherapy cycle to find early signs of heart and vascular damage. This information will help develop an algorithm for early detection of heart complications in AML patients receiving chemotherapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute myeloid leukemia receiving anthracycline-containing chemotherapy aged 18 to 65 years
  • No clinical signs of heart failure
  • Left ventricular ejection fraction above 50% before starting chemotherapy
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • History of stroke (acute cerebral circulation disorder)
  • History of heart attack (myocardial infarction)
  • Diagnosis of type I or II diabetes mellitus
  • Chronic kidney disease stages C1 to C5
  • Stable angina functional classes III or IV
  • Unstable angina pectoris
  • Atrial fibrillation or flutter
  • Arterial hypertension grades 2 or 3
  • Other cancer diseases
  • Acute inflammatory diseases
  • Thyroid gland diseases
  • Previous treatment with monoclonal antibodies
  • Positive test for HIV, hepatitis B, or hepatitis C
  • Alcohol or drug addiction
  • Neuroleukemia or extramedullary leukemia lesions
  • Refusal to be examined or continue examination
  • Life-threatening situations occurring during the study
  • Development of diseases related to exclusion criteria during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 10 months

Participants undergo comprehensive diagnostic tests before starting chemotherapy and after each course of chemotherapy, including blood tests, echocardiography, laser Doppler flowmetry, ultrasound, and other assessments to monitor heart and endothelial function.

Visits within 1 week after each chemotherapy course

Trial Site Locations

Total: 1 location

1

Clinics of the Samara Medical University

Samara, Samara Oblast, Russia, 443079

Actively Recruiting

Loading map...

Research Team

I

Igor Davydkin, Doctor of Medical Sciences

A

Angelika Antipova

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Similar Trials

A Phase Ib/II Multi-center Open Clinical Trial of Clifutinib...

Acute Myeloid Leukemia, Adult

Actively Recruiting

1 location

Intensive Blood Pressure Control During Cardiotoxic Breast C...

Breast Cancer

Actively Recruiting

7 locations

A Phase 1/2 Study of Hydroxyurea Plus Valproic Acid or 6-Mer...

Acute Myeloid Leukemia, Adult

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here