Cardiac CARE
Research type
Research Study
Full title
A multicentre prospective randomised open-label blinded end-point controlled trial of high-sensitivity cardiac troponin I-guided combination angiotensin receptor blockade and beta blocker therapy to prevent cardiac toxicity in breast cancer and lymphoma patients receiving anthracycline adjuvant therapy
IRAS ID
213164
Contact name
Fiach O'Mahony
Contact email
Eudract number
2017-000896-99
ISRCTN Number
ISRCTN24439460
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
Research Summary
Background
Breast cancer is common. The lifetime risk of women developing breast cancer in the UK is 1 in 8. Survival continues to improve. This improved survival is in part down to chemotherapy drugs called anthracyclines. This medication can cause the unwanted side effect of heart muscle injury. Breast cancer and lymphoma survivors have increased rates of heart problems including heart muscle failure.
Research questions:
We aim to test whether tablet medications called angiotensin receptor blockers (ARB) and B-blockers can prevent heart muscle injury related to chemotherapy. These medications are well established treatments for improving symptoms and survival in patients with heart failure.
We will examine a blood test called cardiac troponin I which can detect very slight heart muscle injury. In the trial only patients with increased levels of this marker will be treated with ARB and B-blocker.
What will happen to study patients?
Breast cancer or non-Hodgkin lymphoma patients scheduled for anthracycline treatment will be approached to take part. If they give consent they will have a detailed magnetic resonance imaging (MRI) scan of their heart prior to starting chemotherapy. Patients receiving anthracycline have blood taken routinely 2 to 3 days before each cycle. Cardiac troponin I levels will be measured on these blood samples. Patients who have an elevation in cardiac troponin I will be allocated at random to treatment with a combination of ARB and B-blocker or standard care.
What is measured in the study?
The main measurement is whether ARB and B-blocker can prevent the decline in heart muscle function measured on MRI. We will follow-up patients to measure health events such as heart failure. The study will show whether a convenient blood test can detect those at risk of heart failure.Summary of Results
The improved survival for patients with cancer is in part down to chemotherapy drugs called anythracyclines. This medication can cause the unwanted side effect of heart muscle pump injury in a minority of patients. Cancer survivors have increased rates of heart problems including heart muscle pump failure.
Research questions
The Cardiac CARE Trial tested whether tablet medications called angiotensin receptor blockers and Bblockers, taken together (cardioprotection therapy), can prevent heart muscle injury related to chemotherapy. These medications are treatments used by doctors for heart pump failure. We examined whether a blood test called high sensitivity cardiac troponin I can detect very slight heart muscle injury and predict future problems with heart pump failure.
What we did
In the trial, only patients with increased levels of the troponin blood test marker were treated with cardioprotection therapy. Breast and blood cancer patients receiving anthracycline treatment were approached to take part. After giving consent they had a detailed scan of their heart prior to starting and 6 months after completing anthracycline chemotherapy. Patients receiving anthracycline had blood taken routinely 2 to 3 days before each treatment. Cardiac troponin levels were measured on these blood samples and patients with an increased level were allocated at random to treatment with cardioprotection therapy or to normal care.
Research Findings
We found no evidence that cardioprotection therapy prevented decline in heart function in anthracycline treated patients with elevated cardiac troponin levels. Patients with no increased troponin level had a similar decline in heart function. It was reassuring that the amount of heart pump function decline following anthracycline chemotherapy was small. We believe the results show that use of cardioprotection therapy is not effective and may not be required for most patients.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0071
Date of REC Opinion
19 Jun 2017
REC opinion
Further Information Favourable Opinion