NCT05703126 Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML
| NCT ID | NCT05703126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samara State Medical University |
| Condition | Acute Myeloid Leukemia, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-12-01 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Igor Davydkin
PRINCIPAL INVESTIGATOR
Samara State Medical University
Frequently Asked Questions
Who can join the NCT05703126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Myeloid Leukemia, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05703126 currently recruiting?
Yes, NCT05703126 is actively recruiting participants. Contact the research team at i.l.davydkin@samsmu.ru for enrollment information.
Where is the NCT05703126 trial being conducted?
This trial is being conducted at Samara, Russia.
Who is sponsoring the NCT05703126 clinical trial?
NCT05703126 is sponsored by Samara State Medical University. The principal investigator is Igor Davydkin at Samara State Medical University. The trial plans to enroll 100 participants.
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