Cardiomyopathy. Cardiomyopathy due to drug and external agent
Conditions
Interventions
Intervention 1: Intervention group: The patient will be assigned to the intervention group based on the predetermined random plan once the researcher has confirmed that the candidate satisfies all inc
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Female patients aged 18 to 70 years Patients with histologically or cytologically proven primary breast cancer Receiving chemotherapy with doxorubicin, without prior bilateral/unilateral thoracic radiotherapy Karnofsky score more than 60 Life expectancy more than 6 months
Exclusion criteria
Exclusion criteria: Patients diagnosed with cardiomyopathy Patients receiving vitamin K antagonists or DOACs Patients with chronic kidney disease with eGFR < 30 ml/min/1.73 m2 Patients with serum potassium above 5.5 mmol/L Patients with severe liver failure (Child-Pough C) Patients who have previously received anthracycline Patients who are currently pregnant or breastfeeding Patients participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of heart failure in study subjects. Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Based on the findings of echocardiography, including ejection fraction and Global Longitudinal Strain (GLS) of the heart, cardiac biomarkers, and ECG according to the definition of the European Heart Association in 2022. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prooxidant-Antioxidant Balance (PAB). Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Laboratory kit.;Drug adherence. Timepoint: Monthly. Method of measurement: Pill count. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Sistanizad
Shahid Beheshti University of Medical Sciences
Outcome results
None listed