Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes

Not Applicable

Active, not recruiting

• Conditions: Cardiotoxicity from cancer chemotherapy; Cardiovascular - Other cardiovascular diseases; Cancer - Any cancer

• Registration Number: ACTRN12614000341628
• Lead Sponsor: Menzies Research Institute Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 331

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified