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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention therapy | Experimental | Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
|
| Conventional therapy | No Intervention | No intervention | |
| Global longitudinal strain (GLS) function decreased >15%, No intervention | No Intervention | With the value of GLS function via echocardiography study decreased >15%, No intervention | |
| GLS function descending >15%, Rescue therapy | Experimental | Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention therapy | Drug | Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction value measured by echocardiography | Left ventricular ejection fraction by cardiac echo | 1 year |
| Heart failure hospitalization | admission due to heart function deterioration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping-Yen Liu, PhD. | Contact | +8862353535 | 3656 | larry@mail.ncku.edu.tw |
| Pei-Tien Hsu | Contact | +8862353535 | 4602 | sz2137@yahoo.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ping-Yen Liu, MD, PhD | National Cheng Kung University Hospital, Tainan, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Recruiting | Tainan | Taiwan |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D006333 | Heart Failure |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Rescue therapy |
| Drug |
Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
|
| 1 year |
| All-cause mortality | All types of death | 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 | 1 year |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |