Randomised controlled trial (RCT) of chemotherapy patients at risk of cardiotoxicity undergoing cardioprotection guided by measurement of LV strain compared with cardioprotection guided by measurement of left ventricular (LV) ejection fraction for avoidance of cardiotoxicity

Menzies Research Institute Tasmania0 sites331 target enrollmentMarch 31, 2014

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Menzies Research Institute Tasmania

•i. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity;
•use of anthracycline WITH current (but not necessarily concurrent)
•trastuzumab (Herceptin) in breast\-cancer with the HER2 mutation OR
•tyrosine kinase inhibitors (eg sunitinib) OR
•cumulative anthracycline dose \>450g/m2 of doxorubicin, or equivalent other anthracycline cumulative dose (eg for epirubicine \>900g/m2\).OR
•increased risk of HF (any two of age \>65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. 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
•\- Valvular stenosis or regurgitation of \>moderate severity
•\- History of previous heart failure (baseline NYHA \>2\)
•\- Systolic BP \<110mmHg
•\- Pulse \<60/minute
•\- Inability to acquire interpretable images (identified from baseline echo)
•\- Contraindications/Intolerance to beta blockers or ACE inhibitors
•\- Existing therapy with both beta blockers and ACE inhibitors
•\- 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