PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?

Exclusion Criteria

• •Positive baseline cardiac troponin T (≥14ng/L);
• •known contraindication to ACE inhibitor e.g. renal artery stenosis, severe aortic stenosis;
• •are taking, or have a previous intolerance to ACEI (e.g. angioedema);
• •patient already taking other agents acting on the renin-angiotensin-aldosterone system e.g. Aliskiren, angiotensin receptor blockers (ARBs), Entresto (sacubitril/valsartan), spironolactone, eplerenone;
• •LVEF \<50%\*;
• •estimated GFR \< 30 mL/min/1.73m2 at baseline;
• •hyperkalaemia defined as serum potassium ≥5.5mmol/L;
• •symptomatic hypotension, or Systolic Blood Pressure \<100mmHg;
• •poorly-controlled hypertension (Blood Pressure \>160/100mmHg\*\*, or ambulatory BP of 150/95mmHg);
• •previous myocardial infarction;
• •known metastatic breast cancer;
• •previous exposure to anthracycline chemotherapy;
• •are pregnant or breastfeeding;
• •previous Herceptin treatment or planned Herceptin treatment within four weeks following anthracycline chemotherapy;
• •for patients of childbearing potential: refusal to use adequate contraception throughout the trial;\*\*\*
• •any other invasive cancer diagnosed and treated in the past 5 years;
• •symptomatic or severe asymptomatic radiation-induced cardiac disease;
• •judgement by the investigator that the patient has a prognosis of \< 1 year or are unlikely to complete 6 cycles of chemotherapy;
• •judgement by the investigator that the patient is high risk for tumour lysis syndrome (applicable only to NHL patients);
• •judgement by the Investigator that the patient should not participate in the study, for example, if the patient is unlikely to comply with study procedures, restrictions, and requirements.
• •\*\<50% as defined by Simpson's biplane method; if absolute measurements are not possible, then a visually normal assessment of LVEF is acceptable for inclusion.
• •\*\*White coat hypertension is more common, and should be ruled out by an ambulatory blood pressure monitor
• •\*\*\*Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline. Adequate methods of contraception are those that can achieve a failure rate of less than
• •1% per year when used consistently and correctly, such methods include:
• •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
• •* oral
• •* intravaginal
• •* transdermal
• •progestogen-only hormonal contraception associated with inhibition of ovulation
• •* oral
• •* injectable
• •* implantable
• •intrauterine device (IUD)
• •intrauterine hormone-releasing system (IUS)
• •bilateral tubal occlusion
• •vasectomy/vasectomised partner
• •true sexual abstinence