NCT05892146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4.7 years

First QC Date

May 26, 2023

Last Update Submit

June 6, 2023

Conditions

Chemotherapeutic ToxicityCardiotoxicityHeart FailureBreast CancerLymphoma

Outcome Measures

Primary Outcomes (1)

  • Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain

    Left ventricular global peak systolic longitudinal strain by cardiac echo

    1 year

Secondary Outcomes (4)

  • Change in left ventricular ejection fraction value measured by echocardiography

    1 year

  • Heart failure hospitalization

    1 year

  • All-cause mortality

    1 year

  • Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)

    1 year

Study Arms (4)

Prevention therapy

EXPERIMENTAL

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Drug: Prevention therapy

Conventional therapy

NO INTERVENTION

No intervention

Global longitudinal strain (GLS) function decreased >15%, No intervention

NO INTERVENTION

With the value of GLS function via echocardiography study decreased \>15%, No intervention

GLS function descending >15%, Rescue therapy

EXPERIMENTAL

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Drug: Rescue therapy

Interventions

Prevention therapyDRUG

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Prevention therapy
Rescue therapyDRUG

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

GLS function descending >15%, Rescue therapy

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

CardiotoxicityHeart FailureBreast NeoplasmsLymphoma

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Ping-Yen Liu, MD, PhD

    National Cheng Kung University Hospital, Tainan, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping-Yen Liu, PhD.

CONTACT

+8862353535larry@mail.ncku.edu.tw

Pei-Tien Hsu

CONTACT

+8862353535sz2137@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor/Professor

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 7, 2023

Study Start

May 5, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)