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WELCOME TO THE EVEREST TRIAL

EVEREST - A Randomised Controlled Trial of Renin-Angiotensin System Inhibition for Reduction of Cardiovascular Events after Takotsubo Cardiomyopathy

What is EVEREST?

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.

This risk is much the same for patients who have had a heart attack. However, unlike heart attacks, there are no proven treatments for takotsubo cardiomyopathy. Although similar medications as those prescribed to patients with heart attacks have been used, we currently do not know if these drugs are effective in treating takotsubo cardiomyopathy, and recent data suggest they may not be. This means there is an absence of any evidence to guide treatment decisions.

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.

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Who will be taking part?

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.

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If you are interested in taking part, or have any questions

CONTACT US

Where can I take part?

NHS Grampian -Aberdeen Royal Infirmary

Key people:

Investigator:

  • Dr Calum Creaney

Address:

Cardiovascular Research Facility
Yellow Zone
Level 1
Aberdeen Royal Infirmary
AB25 22N
NHS Golden Jubilee -Glasgow

Key people:

Investigator:

  • Dr Paul Rocchiccioli

Address:

Golden Jubilee Research Institute
Beardmore Street
Clydebank
G81 4HX
NHS Highland - Raigmore Hospital, NHS Highland

Key people:

Investigator:

  • Prof Stephen Leslie

Address:

NHS Highland Clinical Research Facility
Research, Development and Innovation Department
UHI House (Formerly Centre for Health Science)
Old Perth Road, Inverness
IV2 3JH
NHS Lothian - Royal infirmary and Western General hospitals

Key people:

Investigator:

  • Dr Peter Henriksen

Address:

Cardiology Research
Team Room S2333 (opposite ward 204)
Royal Infirmary of Edinburgh, 51 Little France Cre
Edinburgh
EH16 4ST
RAE Infirmary, Wrightington, Wigan and Leigh

Key people:

Investigator:

  • Dr Usman Ali

Address:

Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
Royal Berkshire Foundation NHS Trust

Key people:

Investigator:

  • Prof Neil Ruparelia

Address:

R&I , North Block,
Level 2, Royal Berkshire Hospital
London Road
Reading, Berkshire
RG15AN
North Tyneside General, Northumbria Healthcare NHS Foundation Trust North

Key people:

Investigator:

  • Prof David Ripley

Address:

Consultant Cardiologist
North Tyneside Hospital
Rake Lane
North Shields
NE29 8NH
King's College Hospital NHS Foundation Trust

Key people:

Investigator:

  • Dr Nilesh Parek

Address:

King's College Hospital
Denmark Hill
London
SE5 9RS
University Hospitals Plymouth NHS Trust

Key people:

Investigator:

  • Dr Ben Sieniewicz

Address:

University Hospitals Plymouth NHS Trust
The Research Office, Level 2 MSCP
Bircham Park Offices, 1 Roscoff Rise, Derriford
Plymouth
PL6 5FP
South Tyneside and Sunderland NHS FT

Key people:

Investigator:

  • Dr Alykhan Bandali

Address:

The Education Centre
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
South Tees Hospital NHS FT, James Cook University Hospital, Middlesborough

Key people:

Investigator:

  • Dr James Dundas

Address:

The James Cook University Hospital
Marton Road
Middlesborough
TS4 3BW
NHS Lanarkshire, University Hospital Hairmyres

Key people:

Investigator:

  • Dr David Carrick

Address:

University Hospital Hairmyres
218 Eaglesham Road
Glasgow
G75 8RH
Leeds General Infirmary

Key people:

Investigator:

  • Prof Stephen Wheatcroft

Address:

Leeds Clinical Research Facility
F Floor
Jubilee Wing
LG1
LS1 3EX
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital

Key people:

Investigator:

  • Dr James Richardson

Address:

Northern General Hospital
Herries Road
Sheffield
S5 7AU
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary

Key people:

Investigator:

  • Dr Mohammed Imran Ansari

Address:

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
Bedfordshire Hospitals NHS Trust

Key people:

Investigator:

  • Dr Ganesan Kumar

Address:

Bedfordshire Hospitals NHS Trust
Lewsey Road
Luton
LU4 0DZ
University Hospital Southampton NHS FT

Key people:

Investigator:

  • Prof Nick Curzen

Address:

University Hospital Southampton NHS FT
Tremona Road
Southampton
SO16 6YD
Somerset NHS Foundation Trust, Musgrove Park Hospital

Key people:

Investigator:

  • Dr Osama Samra

Address:

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
Somerset NHS Foundation Trust, Yeovil Hospital

Key people:

Investigator:

  • Dr Andrew Broadley

Address:

Yeovil Hospital
Higher Kingston
Yeovil
BA21 4AT

Study news

Recruitment

25/1080

Trial sites

Latest addition to sites:

Somerset NHS Foundation Trust, Yeovil Hospital
Somerset NHS Foundation Trust, Musgrove Park Hospital
University Hospital Southampton NHS FT
Bedfordshire Hospitals NHS Trust

Key facts about the study and documents

What is this study about?

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).

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You can find out more information about EVEREST here:

Download documents:

Key contacts

Click on cards to find out more

Key questions & answers

Click on questions to find out more

What are the possible benefits of taking part?

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.

What are the possible disadvantages, risks or side effects of 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.

Organisation

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.

General Data Protection Regulation (GDPR)

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