Clinical trial · Interventional
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells. Anthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. However, the clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio-oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders and diseases of the pericardium. Anthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy. Purpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters. Expected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Endothelial Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anthropometry | Diagnostic Test | — | UNRESOLVED |
| Biochemical blood test | Diagnostic Test | — | UNRESOLVED |
| Coagulogram | Diagnostic Test | — | UNRESOLVED |
| Complete blood count | Diagnostic Test | — | UNRESOLVED |
| Cytogenetic examination of the bone marrow to determine genetic abnormalities. | Diagnostic Test | — | UNRESOLVED |
| Cytological examination of bone marrow cells with cytochemical examination | Diagnostic Test | — | UNRESOLVED |
| Determination of the presence of a FLT3 mutation using the PCR Method | Diagnostic Test | — | UNRESOLVED |
| Electrocardiography |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- The study group
- description
- The study group will include patients with acute myeloid leukemia receiving chemotherapy, aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before the start of polychemotherapy, in whom in the course of chemotherapy treatment after the next course of treatment a decrease in global longitudinal strain of 15% or more relative to the initial values will be revealed.
- interventionNames
- Diagnostic Test: History taking
- Diagnostic Test: Anthropometry
- Diagnostic Test: Complete blood count
- Diagnostic Test: Biochemical blood test
- Diagnostic Test: Coagulogram
- Diagnostic Test: Immunoenzymatic analysis of the level of endothelin-1, asymmetric dimethylarginine
- Diagnostic Test: Stress echocardiography with the definition of global longitudinal deformation of the myocardium
- Diagnostic Test: Triplex scanning of neck vessels
- Diagnostic Test: Electrocardiography
- Diagnostic Test: Ultrasound of the abdominal cavity (with calculation of the area of the spleen) and lymph nodes
- Diagnostic Test: Cytogenetic examination of the bone marrow to determine genetic abnormalities.
- Diagnostic Test: Cytological examination of bone marrow cells with cytochemical examination
- Diagnostic Test: Immunophenotypic examination of the bone marrow by flow cytometry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available