Cessation Of Pharmacotherapy In Recovered Chemotherapy induced cardioToxicity (COP-RCT) – a pilot study

Not Applicable

Recruiting

• Conditions: Recovered chemotherapy induced cardiotoxicity; Cardiovascular - Other cardiovascular diseases; Cancer - Any cancer

• Registration Number: ACTRN12621000928819
• Lead Sponsor: epean Blue Mountains Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-15
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Previously diagnosed asymptomatic chemotherapy related cardiac dysfunction (CTRCD) (defined as: LVEF drop >10% to a value below <55% from baseline or GLS drop greater than or equal to 12% from baseline)

LVEF of >50%.

NYHA Class I

Current CTRCD therapy – Angiotensin Converting Enzyme inhibitor (ACEi) AND/OR Beta Blocker (BB)

Completed HER2 receptor therapy (traztuzumab/pertuzumab)

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
• < 16 years old

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular Ejection Fraction (LVEF) by cardiac magnetic resonance. [ 6 months post-randomisation]