Evaluating heart function in acute myeloid leukemia patients undergoing chemotherapy
Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia
This study is testing how anthracycline chemotherapy affects heart function in adults with acute myeloid leukemia to help improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Samara State Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Samara, Samara Oblast) |
| Trial ID | NCT05703126 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of anthracycline chemotherapy on heart function in patients with acute myeloid leukemia (AML). It focuses on assessing endothelial dysfunction and myocardial contractility in individuals aged 18 to 65 who are receiving anthracycline-containing treatment regimens. The methodology includes comprehensive patient evaluations such as history taking, anthropometry, complete blood counts, biochemical tests, and coagulograms. The goal is to understand the cardiotoxic effects associated with AML treatments and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with acute myeloid leukemia receiving anthracycline chemotherapy and without clinical signs of heart failure.
Not a fit: Patients with a history of significant cardiovascular issues or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for preventing cardiotoxicity in AML patients undergoing chemotherapy.
How similar studies have performed: Other studies have indicated significant concerns regarding cardiotoxicity in similar patient populations, suggesting that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Samara, Samara Oblast
- Clinics of the Samara Medical University — Samara, Samara Oblast, Russia (Recruiting)
Study contacts
- Principal investigator: Igor Davydkin — Samara State Medical University
- Study coordinator: Igor Davydkin, Doctor of Medical Sciences
- Email: i.l.davydkin@samsmu.ru
- Phone: 89270145544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.