Clinical trial NCT05892146: Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction
Official title: Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapeutic Toxicity
Cardiotoxicity
Heart Failure
Breast Cancer
Lymphoma
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
timeFrame: 1 year
Secondary outcomes:
measure: Change in left ventricular ejection fraction value measured by echocardiography
timeFrame: 1 year
measure: Heart failure hospitalization
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 1 year
measure: Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University Hospital, Tainan, Taiwan
name: Ping-Yen Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: