Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

NCT05892146 — Not applicable, Unknown, 100 participants, National Cheng-Kung University Hospital

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Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients

RegistryNCT05892146
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment100 (Estimated)
SponsorNational Cheng-Kung University Hospital (Other)
ConditionsChemotherapeutic Toxicity, Cardiotoxicity, Heart Failure, Breast Cancer, Lymphoma
InterventionsPrevention therapy, Rescue therapy (Drug)
Datesstart 2021-05-05, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-06-07, last updated 2023-06-07
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Chemotherapeutic Toxicity All trials for Cardiotoxicity All trials of Prevention therapy All trials of Rescue therapy

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Prevention therapyExperimentalDrug: Prevention therapySacubitril/Valsartan (25/80) mg twice a day for 1 year
Conventional therapyNo interventionNo intervention
Global longitudinal strain (GLS) function decreased >15%, No interventionNo interventionWith the value of GLS function via echocardiography study decreased >15%, No intervention
GLS function descending >15%, Rescue therapyExperimentalDrug: Rescue therapySacubitril/Valsartan (25/80) mg twice a day for 1 year
  • Prevention therapy (Drug): Sacubitril/Valsartan (25/80) mg twice a day for 1 year
  • Rescue therapy (Drug): Sacubitril/Valsartan (25/80) mg twice a day for 1 year

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 20 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
National Cheng Kung University HospitalTainanTaiwanRecruiting

+Investigators