A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
This study is for people with a common type of heart failure called 'heart failure with preserved ejection fraction' (HFpEF), especially if they also have obesity or type 2 diabetes. In HFpEF, the heart can't relax well enough to pump blood effectively, causing breathlessness and tiredness. Current treatments are limited. This research will test if a special 12-week low-calorie diet can improve heart function, symptoms, and how well people can exercise. Some participants will receive this diet, while others get standard care before potentially trying the diet later. The study hopes to find new ways to help people feel better and improve their heart health.
At a glance
What is this study about?
This study is looking into a type of heart problem called 'heart failure with preserved ejection fraction', often shortened to HFpEF. It's quite common, especially in people who also have obesity or type 2 diabetes. With HFpEF, your heart muscle can't properly relax between beats to fill with enough blood. This means it struggles to pump blood effectively around your body, which can lead to symptoms like feeling very breathless, fluid building up, and finding it hard to do physical activities like walking or climbing stairs.
Currently, there aren't many treatments that specifically target HFpEF, so finding new ways to help people feel better is really important. Previous studies have shown that a low-calorie diet might help improve how the heart works and even reverse some of the changes that happen in the heart and blood vessels, especially in people with obesity and diabetes. This new study wants to see if these promising results can also be achieved in a larger, more diverse group of people who already have symptoms of HFpEF.
The researchers will invite 63 adults to take part. For 12 weeks, participants will be put into one of two groups: one group will follow a special low-calorie meal replacement plan, and the other group will receive standard care, which includes advice on healthy weight loss, and then they'll have the option to try the low-calorie diet after 12 weeks. The main goal is to find out if losing weight through this diet can improve how your heart works, reduce your symptoms, and make it easier for you to be active. They will also talk to participants about their experiences with the diet and how it affected their symptoms, which will help doctors plan better care in the future, taking into account different cultural backgrounds.
Key takeaways
- This study explores a low-calorie diet for a common heart condition (HFpEF).
- It targets people with HFpEF who also have obesity or type 2 diabetes.
- The goal is to see if diet can improve heart function, symptoms, and exercise ability.
- Participation involves following a diet or receiving standard care, plus health checks.
- Findings could lead to new ways to manage HFpEF.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult (18 or older) who has been diagnosed with heart failure where your heart's pumping ability is still reasonably strong (doctors call this 'preserved ejection fraction'). You should also have been stable for at least three months, meaning no recent hospital stays due to your heart failure. Additionally, you need to be considered overweight or obese, based on your body mass index (BMI).
There are several reasons why someone might not be able to join. For example, if you can't walk for six minutes, have certain other heart conditions (like specific types of infiltrative or congenital heart disease), severe lung conditions, severe kidney disease, or very low red blood cell count (anaemia). You also can't take part if you've had significant weight loss recently, problematic gallstones, a history of bariatric surgery in the last three years, or specific mental health conditions including active eating disorders.
Women who are pregnant or planning to get pregnant, or anyone already taking part in another study that might affect their diet or weight, also won't be able to join. The study also cannot include individuals with Type 1 diabetes.
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.
- Are you 18 years old or older?
- Have you been diagnosed with heart failure with preserved ejection fraction (HFpEF) by a doctor?
- Has your heart failure been stable for at least 3 months (no recent hospital stays)?
- Do you have a BMI that's considered overweight or obese (check with your doctor)?
- Are you able to walk and undertake a 6-minute walk test?
- Are you willing and able to follow a low-calorie meal replacement plan?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to one of two groups. One group will follow a special low-calorie meal replacement plan for 12 weeks. The other group will receive standard care and health advice on how to lose weight for 12 weeks, and then they'll have the option to try the low-calorie diet afterwards.
During the study, you'll have several check-ups and tests. These include blood tests, heart scans (CMR imaging and echocardiograms), an ECG to check your heart's electrical activity, and a 6-minute walk test to see how far you can walk. We’ll also measure your muscle strength, track your physical activity with a special device called an accelerometer, and ask you about your quality of life and heart failure symptoms. Some participants will also have an optional interview to share their experiences and views on the diet. The main part of the study lasts 12 weeks.
Potential risks and benefits
Locations (3)
- University of Leicester, Glenfield Hospital, Groby RoadVerified postcodeLeicester, United Kingdom· Recruiting
- University of Manchester, Wythenshawe Hospital, Southmoor RoadVerified postcodeManchester, United Kingdom· Recruiting
- University of Oxford, John Radcliffe Hospital, Headley WayVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is HFpEF?
HFpEF is a type of heart failure where your heart muscle can't relax properly between beats, making it hard for blood to fill and then be pumped effectively.
Why is a low-calorie diet being studied?
Previous research has shown that a low-calorie diet might help improve heart function and reverse some heart changes, especially in people with obesity and type 2 diabetes.
What kind of diet is it?
It's a special low-calorie meal replacement plan, designed to be strict for 12 weeks, to see if rapid weight loss can benefit your heart.
Will I have to do a lot of tests?
Yes, you'll have various tests like blood tests, heart scans, an ECG, and a walking test to monitor your progress and health throughout the study.
What happens after 12 weeks?
The main part of the study looking at the diet lasts 12 weeks. If you were in the standard care group, you might then get the option to try the low-calorie diet.
How to find out more
Sarah L Ayton, MBBS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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