Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are newly diagnosed with breast cancer or lymphoma and never accepted anti-cancer therapy
- •Age 20-65 years old
- •Systolic blood pressure ≥ 110 mmHg
排除标准
- •End-stage renal disease (estimated Glomerulus Filtration Rate <15 mL/min/1.73 m2)
- •Echocardiography Baseline left ventricle ejection fraction < 50%
- •Allergy history to angiotensin receptor blockers
- •Life expectancy < 1 year
- •Pregnancy
- •Unwilling to participate in this clinical study
研究组 & 干预措施
Prevention therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
干预措施: Prevention therapy (Drug)
GLS function descending >15%, Rescue therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
干预措施: Rescue therapy (Drug)
结局指标
主要结局
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
时间窗: 1 year
Left ventricular global peak systolic longitudinal strain by cardiac echo
次要结局
- Change in left ventricular ejection fraction value measured by echocardiography(1 year)
- Heart failure hospitalization(1 year)
- All-cause mortality(1 year)
- Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)(1 year)
研究者
Ping-Yen Liu
Doctor/Professor
National Cheng-Kung University Hospital