The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. The investigators planned an earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography. The investigators aim to assess the protective and therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Also, the Patient Recruitment System support to complete the patients' database. The investigators cooperate with other hospitals in South Taiwan to carry on an early phase clinical trial, named "Strategy by novel anti-heart failure therapy on early phase Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD) patients" focusing on the either preventive strategy to earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography, and collect clinical and genetic information from the enrolled patients. These patients randomized into 2 groups: cardioprotective drug vs. placebo. The regular assessment of cardiac function is as following: baseline (prior to anti-cancer treatment) and every 3 months. Thereafter. The investigators aim to assess the protective and/or therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGChange in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
Left ventricular global peak systolic longitudinal strain by cardiac echo
Time frame: 1 year
Change in left ventricular ejection fraction value measured by echocardiography
Left ventricular ejection fraction by cardiac echo
Time frame: 1 year
Heart failure hospitalization
admission due to heart function deterioration
Time frame: 1 year
All-cause mortality
All types of death
Time frame: 1 year
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
Cardiac biomarkers (NT-proBNP and hs-cTnT) changes
Time frame: 1 year
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