Takotsubo cardiomyopathy can be triggered by sudden stress such as bad news, or the physical stress from another illness, or in some cases there is no known cause. The symptoms of takotsubo cardiomyopathy are like a heart attack, but unlike a heart attack are not caused by a blockage in the heart arteries but by a severe weakening of the heart muscle. It remains unclear to doctors what causes this muscle weakness. After the acute takotsubo episode, the heart muscle recovers by itself in a matter of a few days to a few weeks. However, in the longer term, there is a higher risk of further health problems including heart attacks, strokes and heart failure as well as a repeat of takotsubo episodes.
Renin Angiotensin System (RAS) inhibitors (angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)) are a type of drug that helps relax blood vessels and lower blood pressure. They are commonly used to treat heart attacks and heart failure and are sometimes prescribed after a takotsubo cardiomyopathy.
The EVEREST study is investigating how effective these RAS inhibitors (ACEi/ARB) are in the long term after a takotsubo cardiomyopathy. It will help answer the question on whether RAS inhibitors (ACEi/ARB) should, or should not, be prescribed to patients after a takotsubo cardiomyopathy. Half the people who take part in EVEREST will be prescribed RAS inhibitors and half will not (though if they need to be prescribed a RAS inhibitor while taking part, they can be). We will follow up participants in the EVEREST study for a minimum period of two years. During this time, we will ask participants to fill in a questionnaire each year to find out how they are getting on.
We are recruiting adult women and men in the UK who have been diagnosed with acute takotsubo cardiomyopathy in the previous six months (either a first episode or a recurrent episode).
Please see “Where can I take part?” to check if your local hospital is participating.
If you would like to know more about EVEREST, including information about taking part, please email the EVEREST study office at the University of Aberdeen: everest@abdn.ac.uk
There is also a link below to the EVEREST patient information leaflet.
If you are allocated to the group who are not prescribed a RAS inhibitor (no ACEi/ARB) you should continue taking any other medication (if applicable) as normal.
Whichever group you are in, you will be in the EVEREST study for a minimum period of two years, but you do not need to return in person for study visits. We will send you the study questionnaire through the post (or by email if you prefer to complete the questionnaire on-line) 30 days after you join the study, and again after 3, 6 months and at each year that you are in the study.
The questionnaires are returned to the study office in a prepaid envelope which we will provide, or online.
What are RAS inhibitors?
RAS inhibitors are generally used to treat hypertension (high blood pressure), heart failure or heart attacks. There are two main types of RAS inhibitors:
1. Angiotensin converting enzyme (ACE) inhibitors, which include drugs like Ramipril, Lisinopril, Perindopril, Fosinopril and Captopril.
2. Angiotensin II receptor blockers (ARB), which include drugs like Valsartan, Candesartan, Losartan, Irbesartan, Telmisartan and a combination called Entresto (Sacubitril-Valsartan).
By taking part, you will be directly helping to inform the treatment of future patients with takotsubo cardiomyopathy. The results of this study will help plan effective services offered by the NHS in the future. We expect the results of this study to feed directly into the NHS guidelines and, for the first time, provide evidence for the treatment of takotsubo cardiomyopathy. As with any research, you may not benefit personally from taking part.
We do not think there are any major disadvantages to you.
For those prescribed a RAS inhibitor (ACEi/ARB), the risks and side effects of the drug are few and will be explained to you by the study team. Before you agree to take part in the study, you can and should discuss any concerns that you may have with your doctor.
Funding acknowledgement
This study is funded by the NIHR Health Technology Assessment (HTA) programme (NIHR 157523) and run by the University of Aberdeen, in conjunction with NHS Grampian. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS, or the Department of Health & Social Care.
Participant Information
University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 25 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information here:
https://www.abdn.ac.uk/about/privacy/research-participants-938.php or by contacting the Data Protection office at dpa@abdn.ac.uk