Rationale and Design of the Cessation Of Pharmacotherapy In Recovered Chemotherapy-induced cardioToxicity (COP-RCT): A Pilot Study
Date
2024
Authors
Yu, C.
Negishi, T.
Pathan, F.
Sverdlov, A.
Thomas, L.
Shirazi, M.
Koo, C.Y.
Tan, L.L.
Miyazaki, S.
Negishi, K.
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Journal article
Citation
Heart Lung and Circulation, 2024; 33(5):753-757
Statement of Responsibility
Christopher Yu, Tomoko Negishi, Faraz Pathan, Aaron Sverdlov, Liza Thomas, Mitra Shirazi, Chieh Yang Koo, Li Ling Tan, Sakiko Miyazaki, Kazuaki Negishi
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Abstract
Background Cancer therapeutics-related cardiac dysfunction (CTRCD) is a well-recognised complication of cancer treatment. Treatment of CTRCD involves cardioprotective therapy (CPT) which can lead to a recovery of CTRCD with normalisation of the left ventricular ejection fraction (LVEF). As a result, there are potentially millions of cancer survivors with recovered CTRCD on CPT. Cardioprotective therapy can be associated with an undesirable long-term pill burden, financial costs, and side effects. Cancer survivorship is anticipated to increase significantly by the end of this decade. To date, there is no evidence of the safety of stopping CPT in this setting. This study seeks to evaluate the hypothesis that ceasing cardioprotective medication is a feasible and safe option without significant impact on LVEF in low-risk patients who have recovered from CTRCD. Methods and Analysis We will perform a multicentre prospective open-label randomised controlled trial with blinded endpoint (PROBE) of supervised CPT cessation compared to continuing CPT (control). The primary study end point is the change in LVEF by cardiac magnetic resonance imaging at 6 months of enrolment between the two groups. Secondary end points include changes in quality-of-life questionnaires, other cardiac imaging parameters, and recurrence of heart failure. Conclusion Cessation Of Pharmacotherapy In Recovered Chemotherapy-induced cardioToxicity (COP-RCT) is one of the first studies currently underway to evaluate the safety of ceasing CPT in recovered CTRCD. The results will inform clinical practice in this evidence-free zone.
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© 2023 The Authors. Published by Elsevier B.V. on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).