About the Trial
Cardiac CARE is a non-commercial trial sponsored by a partnership of the University of Edinburgh and NHS Lothian called ACCORD and funded by UK National Institute for Health Research (NIHR) and the British Heart Foundation (BHF).
It is a multicentre, prospective, randomised, open-label, blinded end-point clinical trial.
These types of trial aim to make a fair comparison between a new treatment and the standard existing treatment to see if it would be better to use the new treatment in the future. The decision about who gets one treatment or the standard treatment is random – made by chance rather than by a doctor or a participant. This means that researchers can be sure that any differences between the groups are due to the treatment and not to any other factor.
Open-label means that participants are randomised during the trial and they will know straightaway if they are getting treatment or not.
Both groups are equally important: we want to know if the treatment works but we will only know this by carrying out the trial!
Study Background:
1 in 2 people in the UK born after 1960 will be diagnosed with cancer. One of the most common types of cancer is breast cancer. The lifetime risk of women developing breast cancer in the UK is 1 in 8. Non-Hodgkin lymphoma is another type of cancer, the fifth most common cancer in the UK. In non-Hodgkin lymphoma, the blood cells become abnormal and can form tumours.
Survival of both breast cancer and non-Hodgkin lymphoma patients 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 and 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 not in the trial might routinely have radionuclide scans to monitor heart function. 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.
Acknowledgement
This project is jointly funded by the BHF and the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership (www.nihr.ac.uk).
Disclaimer
The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NHS, NIHR or the Department of Health.
*The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland.
