Randomised controlled trial (RCT) of cardioprotection versus usual care for preservation of 12-month MRI ejection fraction in cancer patients with abnormal LV strain but preserved left ventricular (LV) ejection fraction response to chemotherapy

Baker Heart and Daibetes Institute0 个研究点目标入组 1,100 人开始时间: 2020年10月20日最近更新: 2023年11月13日

适应症

试验速览

暂无简介。

•i) Patients undergoing chemotherapy at increased risk of cardiotoxicity due to use of anthracycline (already commenced and up to an including 3rd dose) WITH one of the following (not necessarily concurrently)
•- trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
•- tyrosine kinase inhibitors (eg. sunitinib) OR
•- cumulative anthracycline doses >450mg/m2 OR
•- chest radiotherapy OR
•- treatment for previous cancer (solid or haematological) that involved treatment with anthracycline (any dose) or chest radiotherapy OR
•- increased risk of HF (age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg.e.g. myocardial infarction)
•ii).Live within a geographically accessible area for follow-up
•iii).Are able and willing to provide written informed consent to participate in the study (this includes the ability to communicate fluently with the investigator and that the patient is mentally competent)

•- Unable to provide written informed consent to participate in this study
•- Participating in another clinical research trial where randomized treatment would be unacceptable
•- Ejection fraction at baseline echo <50%
•- Valvular stenosis or regurgitation of >moderate severity
•- History of previous heart failure (baseline NYHA >2)
•- Systolic BP <110mmHg
•- Pulse <60/minute if not on BB
•- Inability to acquire interpretable images (identified from baseline echo)
•- Contraindications/Intolerance to beta blockers or ACE inhibitors
•- Contraindications to MRI
•- Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
•- Taking concurrently ACEi AND BB

发起方

Baker Heart and Daibetes Institute