None listed
Conditions
Brief summary
The purpose of this study is to define the value of strain in patient management, by identification of subclinical left ventricular (LV) dysfunction, which will be used to guide cardioprotective therapy. Who is it for? You may be eligible to join if you are aged between 18 and 80 years old (inclusive), and actively undergoing chemotherapy at increased risk of cardiotoxicity. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will undergo screening echocardiography for the development of cardiotoxicity with the inclusion of myocardial mechanics to measure LV strain. The measurement of LV strain will be used to guide the participant's cardioprotection treatment to avoid cardiotoxicity. Serial screening tests are envisaged to take place at 3 monthly intervals for one year with each screening session taking approximately 30 minutes. Participants in the other group will undergo standard echocardiogram and an ultrasound test of the heart where ejection fraction (EF) is measured. The measurement of EF will be used to guide the participant's cardioprotection treatment to avoid cardiotoxicity. This screening test is envisaged to take place at 3 monthly intervals for a year with each session taking approximately 30 minutes.
Interventions
Inclusion of myocardial mechanics in screening echocardiography for development of cardiotoxicity. Serial screening test for LV strain is envisaged at 3 monthly intervals for a year and the acquisition takes ~30 minutes.
Sponsors
Menzies Research Institute Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
- 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
Outcome results
None listed