ACTRN12620001094965
Recruiting
未知
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 sites1,100 target enrollmentOctober 20, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cardiotoxicity from cancer chemotherapy
- Sponsor
- Baker Heart and Daibetes Institute
- Enrollment
- 1100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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