A multicentre prospective randomised open-label blinded end-point controlled trial of high-sensitivity cardiac troponin I-guided combination angiotensin receptor blockade and beta blocker therapy to prevent cardiac toxicity in breast cancer and lymphoma patients receiving anthracycline adjuvant therapy (Cardiac CARE)

ACCORD - University of Edinburgh & NHS Lothian co-sponsors0 个研究点目标入组 168 人开始时间: 2017年8月8日最近更新: 2023年10月9日

适应症

试验速览

•Current inclusion criteria as of 17/01/2019:
•1. Female or male aged =18 years
•2. Histological diagnosis of invasive breast cancer or non-Hodgkin lymphoma
•3. ECOG performance status 0-1
•4. Planned to commence anthracycline containing therapy:
•4.1. For adjuvant or neo-adjuvant treatment of breast cancer. Breast cancer patients scheduled for =300 mg/m2 cumulative dose epirubicin, or equivalent, over 3, 4 or 6 cycles
•4.2. NHL patients planned to commence =3 cycles of CHOP or R-CHOP therapy containing =300mg/m2 epirubicin equivalent cumulative dose of anthracycline.
•5. A life expectancy of at least 12 months
•6. LVEF = 50% on baseline MRI
•7. Systolic blood pressure = 105 mmHg and =170 mmHg
•8. An eGFR >45 mL/min/1.73 m2
•9. Provide written consent to take part in the study
•Previous inclusion criteria:
•1. Female or male aged =18 years
•2. Histological diagnosis of invasive breast cancer
•3. ECOG performance status 0-1
•4. Planned to commence anthracycline for adjuvant or neo-adjuvant treatment of breast cancer. Patients scheduled for >300 mg/m2 cumulative dose epirubicin or equivalent.
•5. A life expectancy of at least 12 months
•6. LVEF = 50% on baseline MRI
•7. Systolic blood pressure = 105 mmHg and =170 mmHg
•8. An eGFR >45 mL/min/1.73 m2
•9. Provide written consent to take part in the study

•1. Pregnancy or breastfeeding
•2. HER2 positive disease with planned trastuzumab therapy
•3. Uncontrolled arterial hypertension defined as systolic blood pressure on treatment of >170 mmHg
•3. Patients already taking B-blockers, ACEi or ARBs
•4. Contra-indication to ARBs (eGFR = 45 mL/min/1.73 m2, previous hypersensitivity, renal artery stenosis) or B-blockers (asthma, pathological heart block and pathological sinus bradycardia)
•5. Clinically proven intolerance to lactose monohydrate
•6. A history of symptomatic heart failure
•7. Contraindication to or inability to tolerate MRI scanning
•8. Suspected poor drug compliance
•9. Active alcohol or drug abuse
•10. Patients previously treated with anthracyclines or trastuzumab
•11. Uncontrolled concomitant serious illness, as determined by the investigator
•12. Female or male aged <18 years
•13. Not provided written consent to take part in the study
•14. Previously randomised into this trial

发起方

ACCORD - University of Edinburgh & NHS Lothian co-sponsors