Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes measured by Magnetic Resonance Imaging (SUCCOUR-MRI)

Not Applicable

Recruiting

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

• Registration Number: ACTRN12620001094965
• Lead Sponsor: Baker Heart and Daibetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1100

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
- 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
- Taking concurrently ACEi AND BB

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cardiac magnetic resonance (CMR) ejection fraction from baseline to one year, as determined by a blinded core laboratory[ 12 months post baseline]

Secondary Outcome Measures

Name	Time	Method
Development of cardiotoxicity – ie. a categorical analysis of reduced MRI LVEF concordant with the recent guidelines (reduction of LVEF of more than 5% to less than 50% with symptoms of heart failure, or an asymptomatic reduction of LVEF of more than 10% to less than 50%).[ 12 months post baseline];Comparison of the proportion with completion of the planned chemotherapy among groups. Data from medical records.<br>[ 12 months post baseline];Rate of heart failure among groups based on patient history, examination and chart review.[ 36 months post baseline]