The Cardiac CARE Trial – can heart muscle injury related to chemotherapy be prevented?

Phase 2

Completed

• Conditions: Heart muscle injury in patients receiving chemotherapy for breast cancer or non-Hodgkin lymphoma; Circulatory System

• Registration Number: ISRCTN24439460
• Lead Sponsor: ACCORD - University of Edinburgh & NHS Lothian co-sponsors

Brief Summary

2023 Results article in https://doi.org/10.1161/circulationaha.123.064274 (added 25/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2021-11-01
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Current inclusion criteria as of 17/01/2019:
1. Female or male aged =18 years
2. Histological diagnosis of invasive breast cancer or non-Hodgkin lymphoma
3. ECOG performance status 0-1
4. Planned to commence anthracycline containing therapy:
4.1. For adjuvant or neo-adjuvant treatment of breast cancer. Breast cancer patients scheduled for =300 mg/m2 cumulative dose epirubicin, or equivalent, over 3, 4 or 6 cycles
or
4.2. NHL patients planned to commence =3 cycles of CHOP or R-CHOP therapy containing =300mg/m2 epirubicin equivalent cumulative dose of anthracycline.
5. A life expectancy of at least 12 months
6. LVEF = 50% on baseline MRI
7. Systolic blood pressure = 105 mmHg and =170 mmHg
8. An eGFR >45 mL/min/1.73 m2
9. Provide written consent to take part in the study

Previous inclusion criteria:
1. Female or male aged =18 years
2. Histological diagnosis of invasive breast cancer
3. ECOG performance status 0-1
4. Planned to commence anthracycline for adjuvant or neo-adjuvant treatment of breast cancer. Patients scheduled for >300 mg/m2 cumulative dose epirubicin or equivalent.
5. A life expectancy of at least 12 months
6. LVEF = 50% on baseline MRI
7. Systolic blood pressure = 105 mmHg and =170 mmHg
8. An eGFR >45 mL/min/1.73 m2
9. Provide written consent to take part in the study

Exclusion Criteria

1. Pregnancy or breastfeeding
2. HER2 positive disease with planned trastuzumab therapy
3. Uncontrolled arterial hypertension defined as systolic blood pressure on treatment of >170 mmHg
3. Patients already taking B-blockers, ACEi or ARBs
4. Contra-indication to ARBs (eGFR = 45 mL/min/1.73 m2, previous hypersensitivity, renal artery stenosis) or B-blockers (asthma, pathological heart block and pathological sinus bradycardia)
5. Clinically proven intolerance to lactose monohydrate
6. A history of symptomatic heart failure
7. Contraindication to or inability to tolerate MRI scanning
8. Suspected poor drug compliance
9. Active alcohol or drug abuse
10. Patients previously treated with anthracyclines or trastuzumab
11. Uncontrolled concomitant serious illness, as determined by the investigator
12. Female or male aged <18 years
13. Not provided written consent to take part in the study
14. Previously randomised into this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VEF measured using cardiac MRI scan at baseline and 6 months after final anthracycline dose