Heart muscle injury in patients receiving chemotherapy for breast cancer or non-Hodgkin lymphoma Circulatory System
Conditions
Interventions
Current interventions as of 17/01/2019:
Breast cancer and non-Hodgkin lymphoma patients scheduled for anthracycline treatment will be approached to take part. If they give consent they will have a det
Sponsors
ACCORD - University of Edinburgh & NHS Lothian co-sponsors
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 or 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LVEF measured using cardiac MRI scan at baseline and 6 months after final anthracycline dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity of cTnI assay for left ventricular dysfunction: 6-months post treatment LVEF will be recorded with cardiac MRI in all non-randomised participants and compared to baseline LVEF to define the specificity of the hs-cTnI assay for identifying low-risk participants who do not develop left ventricular systolic dysfunction 2. The development of asymptomatic left ventricular dysfunction (a 10 percentage point fall or an LVEF less than 50%), measured with cardiac MRI at 6 months post-anthracycline treatment compared to baseline 3. Resolution of myocardial injury: whether plasma cTnI concentrations return to the normal reference range (<5 ng/L) at 2, 4 and 6 months after chemotherapy 4. Clinical endpoints of death, cardiovascular death and heart failure. Heart failure will be defined by the diagnosis of clinical (symptomatic) heart failure 5. Health economics: the feasibility of data capture and the quality of data obtainable in this patient population, to inform the design of further research including sample size calculation and/or value of information analysis 6. Heart rate and blood pressure at 2, 4 and 6 months following final dose of anthracycline | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactMorag MacLean
Outcome results
None listed