Status:
UNKNOWN
Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy.
Lead Sponsor:
Moscow State University of Medicine and Dentistry
Conditions:
Cardiotoxicity
Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
Advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. Cardiotoxicity is one the most freque...
Eligibility Criteria
Inclusion
- written informed consent form (ICF),
- Eastern Cooperative Oncology Group (ECOG) scale 0-3,
- patients with verified cancer on or planned to be on chemotherapy including anthracyclines,
- sufficient bone marrow function, including: absolute neutrophils \> 1.5\*10\^9/l, platelets \> 100\*10\^9/l, hemoglobin \> 9 g/dl,
- sufficient liver function, including: total bilirubin \< 1.5\*upper normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 upper normal value,
- sufficient renal function, including: creatinine clearance \> 50 ml/min.
- For control group:
- verified non-toxic dilated cardiomyopathy.
Exclusion
- refusal of patient,
- sepsis,
- coma, delirium,
- mental disorders,
- left chest radiation therapy,
- metastases in central nervous system.
Key Trial Info
Start Date :
June 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04055636
Start Date
June 14 2019
End Date
June 1 2024
Last Update
October 18 2021
Active Locations (1)
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1
Moscow State University of Medicine and Dentistry, Department of Hospital Therapy №1
Moscow, Moscow Oblast, Russia, 107095