Echocardiography in Patients Treated with BRAF and MEK Inhibitors
Research type
Research Study
Full title
Echocardiography in Patients Treated with BRAF and MEK Inhibitors
IRAS ID
314516
Contact name
Ninian Lang
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
BRAF and MEK inhibitors are oral anti-cancer drugs which have revolutionised the treatment of melanoma. However, since their introduction it has become clear that these drugs can cause cardiovascular side effects including impaired pumping of the heart (left ventricular systolic dysfunction [LVSD]). The development of LVSD can have a significant impact on patient's physical health as well as leading to dose reduction or withdrawal of cancer treatment.
Package inserts for these medications advise serial echocardiographs (heart ultrasound) to measure left ventricular ejection fraction [LVEF]) while on treatment, to assess heart function. Recent International Cardio-Oncology Society (ICOS) guidelines suggest to measure global longitudinal strain (GLS) in addition to LVEF as this tool can detect changes in heart function prior to a reduction in LVEF.
The purpose of this study is to expand upon a Caldicott approved audit examining the quality and frequency of echocardiograph follow up for patients receiving BRAF/MEK inhibitor drugs at the Beatson West of Scotland Cancer Centre. In line with new ICOS guidelines we will perform GLS analysis on previously collected images to assess if more patients would be classified as having LVSD. We will perform a case note review to assess for associations between baseline characteristics and the development of LVSD. Access to casenotes and echo images to perform strain analysis was previously granted by the Caldicott guardian for audit purposes. Further Caldicott approval will be sought to cover this research study. Patients previously treated with BRAF/MEK inhibitors between 1/6/2017-30/6/2020 will be included. This study will have no impact on the management of patients included because treatment decisions are not currently made on the basis of GLS. The results of this study are important as they will help determine the impact of recent ICOS guidelines change on surveillance for LVSD in patients treated with BRAF and MEK inhibitors.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0191
Date of REC Opinion
12 Aug 2022
REC opinion
Favourable Opinion