Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction
- Conditions
- Chemotherapeutic ToxicityCardiotoxicityHeart FailureBreast CancerLymphoma
- Interventions
- Drug: Rescue therapyDrug: Prevention therapy
- Registration Number
- NCT05892146
- Lead Sponsor
- National Cheng-Kung University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLS function descending >15%, Rescue therapy Rescue therapy Sacubitril/Valsartan (25/80) mg twice a day for 1 year Prevention therapy Prevention therapy Sacubitril/Valsartan (25/80) mg twice a day for 1 year
- Primary Outcome Measures
Name Time Method Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain 1 year Left ventricular global peak systolic longitudinal strain by cardiac echo
- Secondary Outcome Measures
Name Time Method Change in left ventricular ejection fraction value measured by echocardiography 1 year Left ventricular ejection fraction by cardiac echo
Heart failure hospitalization 1 year admission due to heart function deterioration
All-cause mortality 1 year All types of death
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT) 1 year Cardiac biomarkers (NT-proBNP and hs-cTnT) changes
Trial Locations
- Locations (1)
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan