Health Condition 1: null- Patients undergoing chemotherapy and having high risk of cardiotoxixity
Conditions
Interventions
Intervention1: conventional echocardiography: In one group, heart failure will be diagnosed using conventional echocardiography which uses standard two-dimensional, three-dimensional, and Doppler ultr
Sponsors
Medanta The Medicity
Menzies Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity; use of anthracycline WITH (not necessarily concurrently) trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR tyrosine kinase inhibitors (eg sunitinib) OR cumulative anthracycline doses >450g/m2 OR increased risk of HF (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
Exclusion criteria: ï?? Unable to provide written informed consent to participate in this study ï?? Participating in another clinical research trial where randomized treatment would be unacceptable ï?? Valvular stenosis or regurgitation of >moderate severity ï?? History of previous heart failure (baseline NYHA >2) ï?? Systolic BP ï?? Pulse ï?? Inability to acquire interpretable images (identified from baseline echo) ï?? Contraindications/Intolerance to beta blockers or ACE inhibitors ï?? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistent with the study hypothesis, the primary study end-point is change in 3D ejection fraction from baseline to up to three years, as determined by a blinded core laboratory and analyzed on an intention-to-treat basis according to random study group allocation.Timepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (from baseline to up to three years) will be: - Development of cardiotoxicity â?? ie a categorical analysis of reduced LVEF concordant with the recent guidelines (reduction of LVEF of more than 5% to less than 55% with symptoms of heart failure, or an asymptomatic reduction of LVEF of more than 10% to less than 55%). - Comparison of the rate of completion of the planned chemotherapy among groups. - Comparison of the rate of heart failure among groups.Timepoint: 3 years | — |
Countries
Australia, Belgium, Bulgaria, Canada, Germany, India, Italy, Japan, Norway, Romania, Spain
Contacts
Public ContactDr Manish Bansal
Medanta The Medicity
Outcome results
None listed