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COP-RCT

Cessation of pharmacotherapy in recovered chemotherapy induced cardiotoxicity - a pilot study - COP-RCT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030230265
Enrollment
4
Registered
2023-07-29
Start date
2023-07-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Participants will be randomised into two groups in the study: Group 1 Cessation of medical therapy Group 2 Continuation of medical therapy Randomisation will be in random permuted blockers to either g

Sponsors

Miyazaki Sakiko
Lead Sponsor
Sydney University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria Previously diagnosed asymptomatic chemotherapy related cardiac dysfunction (CTRCD) LVEF of >50%. NYHA Class I Current CTRCD therapy Angiotensin Converting Enzyme inhibitor (ACEi) plusminus Beta Blocker (BB) Completed anthracycline AND HER2 receptor therapy

Exclusion criteria

Exclusion criteria: Exclusion criteria: History of ischaemic heart disease Hypertension requiring medical therapy Moderate or greater severity valvular disease Chronic kidney disease Atrial, supraventricular, or ventricular arrhythmia requiring BB therapy Pregnancy under 16 years old Contraindication to cardiac magnetic resonance imaging

Design outcomes

Primary

MeasureTime frame
Change in Left Ventricular Ejection Fraction (LVEF) by cardiac magnetic resonance imaging at six months of enrolment

Secondary

MeasureTime frame
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score Change in EQ-5D questionnaire score Heart failure requiring hospital admission Worsening heart failure requiring medical treatment as adjudicated by the independent cardiologist. Changes in cardiac volumes and functions including global longitudinal strain (GLS) by echocardiographyChanges in cardiac volumes assessed with cardiac MRI Change in blood test values of the following Hs-troponin , NT-proBNP

Countries

Austraria, Japan, Syngapore

Contacts

Public ContactSakiko Miyazaki

Juntendo University, School of Medicine

smiyaza@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026