RecruitingPhase IVInterventional

A randomised controlled trial to find out whether people with takotsubo cardiomyopathy should be prescribed a drug commonly used to relax blood vessels (renin angiotensin system inhibitors)

The Everest Study is testing if a group of common drugs, called RAS inhibitors, can help people who have experienced Takotsubo cardiomyopathy. This heart condition, sometimes called 'broken heart syndrome,' often happens after sudden stress and weakens the heart muscle. Although the heart usually recovers, people remain at a higher risk of future heart problems like heart attacks, strokes, or even another Takotsubo episode. Currently, there isn't a proven long-term treatment for Takotsubo cardiomyopathy. This study wants to find out if RAS inhibitors, which are already used safely for other heart conditions, can prevent these serious health issues and improve quality of life for Takotsubo patients. About 5,000 people in the UK get Takotsubo cardiomyopathy each year, and finding an effective treatment is very important.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University of Aberdeen

Enrolment target

930

Start

01 Jul 2025

Estimated completion

30 Sep 2029

Takotsubo cardiomyopathy

What is this study about?

Imagine your heart suddenly acting up after a really stressful event, like losing a loved one or getting bad news. That's a bit like Takotsubo cardiomyopathy, sometimes nicknamed 'broken heart syndrome.' It affects about 5,000 people in the UK every year, often women, and while the heart muscle usually gets better, people who have had it are still at higher risk for serious problems later on, like heart attacks, strokes, or even having another episode. Currently, there isn't a specific proven treatment for this long-term risk after a Takotsubo attack.

This study, called the Everest Study, wants to see if a group of common medications, known as RAS inhibitors, can make a difference. These drugs are already used safely for other heart conditions, like when someone has had a heart attack due to blocked arteries or has heart failure. Experts think they might also help people with Takotsubo cardiomyopathy by protecting their heart and blood vessels. The main goal is to find out if these drugs can prevent future serious events like another Takotsubo attack, heart attacks, strokes, or heart failure.

By taking part, you would be helping doctors understand if these drugs are truly effective. The results of this study are very important because they could lead to clearer guidelines for how to treat people after a Takotsubo attack for the first time, potentially improving care for future patients across the NHS.

Key takeaways

Tests if common heart drugs can help people after Takotsubo cardiomyopathy.
Aims to prevent serious long-term problems like heart attacks and strokes.
Participation involves taking a drug (or not) for at least two years.
Information collected from NHS records and questionnaires.
Helps shape future NHS guidelines for this condition.
Run by University of Aberdeen, funded by NIHR.

Who may be eligible?

You might be able to take part in this study if you are an adult (18 years or older) and you've had an episode of Takotsubo cardiomyopathy within the last six months. It doesn't matter if it's your first time or if you've had it before.

There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or actively trying to get pregnant. You also can't take part if you already have a medical reason to be taking these types of drugs (RAS inhibitors), or if you've had a known allergic reaction or serious intolerance to them in the past. The study also needs you to be able to understand what's involved and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I had Takotsubo cardiomyopathy in the last 6 months?
Am I 18 years old or older?
Am I able to understand the study and agree to take part?
Am I pregnant or currently breastfeeding?
Do I already take these types of drugs (RAS inhibitors) for a clear medical reason?
Have I had a known severe reaction or intolerance to these drugs before?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups: one group will receive a RAS inhibitor drug, and the other group will not. This allocation is like flipping a coin, so it's fair. You would take the assigned medication for at least two years. The specific dose of the drug will be decided by your doctor, just like they would in their usual care, and they will adjust it if needed, monitoring your blood pressure and kidney function.

The study will collect information about your health from your NHS records, and you'll also be asked to complete some questionnaires. These questionnaires will ask about your symptoms and how you're feeling, and they will be sent out at 30 days, 3 months, 6 months, and then once a year. Each questionnaire should take about 15 minutes to complete. If you find these questionnaires too much, you can choose to stop doing them at any time but still remain part of the study.

Potential risks and benefits

By taking part, you'll be directly contributing to important research that could shape how future patients with Takotsubo cardiomyopathy are treated within the NHS, potentially leading to better health outcomes for many. The main risks of taking RAS inhibitor drugs include feeling lightheaded due to lower blood pressure, or some changes in your kidney function. Your doctor will monitor these to make sure you're safe. If you get side effects with one drug, an alternative from the same drug family can be tried, or the study drug can be stopped altogether if necessary. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

NHS Grampian
Approximate
Aberdeen, United Kingdom

Common questions

What is Takotsubo cardiomyopathy?

It's a heart condition often caused by severe emotional or physical stress. It causes the heart muscle to weaken suddenly, but it's not due to blocked arteries. It's sometimes called 'broken heart syndrome'.

What are RAS inhibitors?

These are a type of medicine commonly used to relax blood vessels, which helps lower blood pressure and can protect the heart and kidneys. Examples include ramipril or candesartan.

How long will the study last for me?

You will take the study drug for at least 2 years, and the study will run overall until December 2031, following up on participants' health during this time.

Will I know if I'm getting the drug or not?

No, it's a 'randomised controlled trial,' meaning you'll be randomly assigned to receive the drug or not, like drawing lots. Neither you nor your doctor will know which group you are in to keep the results fair.

Who is running and paying for this research?

The study is being run by the University of Aberdeen, and it's funded by the National Institute for Health and Care Research (NIHR).

How to find out more

Laura Moir

everest@abdn.ac.uk +44 (0)1224 437421 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.