Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

June 6, 2023 updated by: Ping-Yen Liu, National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevention therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Drug: Prevention therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
No Intervention: Conventional therapy
No intervention
No Intervention: Global longitudinal strain (GLS) function decreased >15%, No intervention
With the value of GLS function via echocardiography study decreased >15%, No intervention
Experimental: GLS function descending >15%, Rescue therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Drug: Rescue therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
Time Frame: 1 year
Left ventricular global peak systolic longitudinal strain by cardiac echo
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in left ventricular ejection fraction value measured by echocardiography
Time Frame: 1 year
Left ventricular ejection fraction by cardiac echo
1 year
Heart failure hospitalization
Time Frame: 1 year
admission due to heart function deterioration
1 year
All-cause mortality
Time Frame: 1 year
All types of death
1 year
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
Time Frame: 1 year
Cardiac biomarkers (NT-proBNP and hs-cTnT) changes
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Ping-Yen Liu, MD, PhD, National Cheng Kung University Hospital, Tainan, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-110-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Prevention therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe