Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Last updated: June 6, 2023
Sponsor: National Cheng-Kung University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Lymphoma

Hyponatremia

Treatment

Prevention therapy

Rescue therapy

Clinical Study ID

NCT05892146
A-BR-110-021
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are newly diagnosed with breast cancer or lymphoma and never acceptedanti-cancer therapy
  • Age 20-65 years old
  • Systolic blood pressure ≥ 110 mmHg

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Prevention therapy
Phase:
Study Start date:
May 05, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Active - Recruiting

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