Breast Cancer, Heart Failure, Cardiotoxicity
Conditions
Interventions
Sponsors
Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female; 2. Patients aged 18-70 years; 3. Definite diagnosis of primary breast cancer; 4. Patients who are ready to receive anthracycline treatment, and the estimated cumulative dose is more than or equal to 240 mg / m2; 5. Patients who have not received bilateral / unilateral chest radiotherapy in the past; 6. Patients with Karnofsky score >= 60; 7. Patients with an estimated survival time of more than 6 months; 8. Randomly assigned patients; 9. Patients who voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients using cardiac drugs within one month, such as angiotensin converting enzyme inhibitors, angiotensin receptor blockers, diuretics, ß - blockers, aldosterone receptor antagonists; 2. Patients diagnosed with cardiomyopathy (ischemic, dilative, restrictive or hypertrophic), moderate or severe aortic and / or mitral valve disease; 3. Patients with systolic blood pressure 180 mmHg; 4. Patients with chronic kidney disease whose EGFR 5.5mmol/l; 6. Patients with severe liver failure; 7. Patients who have used anthracyclines in the past and cannot trace the dosage of drugs; 8. Pregnant and lactating women; 9. Patients who are allergic to the components of the study drug or have contraindications to the use of the study drug; 10. Patients currently participating in clinical trials of other drugs or external therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10%(if the baseline LVEF = 50%) or 5%(if the baseline LVEF< 50%) drop in ejection fraction of left ventricle compared with baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| cTnI;NT-pro-BNP; | — |
Countries
China
Contacts
Public ContactYanwei Xing
Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine
Outcome results
None listed