RecruitingNAINTERVENTIONAL

The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

This study is looking into how weight loss affects people in the UK who have a condition called Heart Failure with Preserved Ejection Fraction (HFpEF) and are also overweight or obese. HFpEF means your heart can't relax properly to fill with blood. Researchers want to find out if losing weight can improve how well your heart pumps blood, changes its shape, and how efficiently it uses energy. They also want to see if it makes a difference to your quality of life and how much you can exercise. Participants will follow either a special diet program or continue with standard care, and attend two study visits over several months.

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

120

Start

20 Jan 2023

Estimated completion

01 Dec 2026

Heart Failure With Preserved Ejection Fraction Obesity

What is this study about?

This study is focusing on a particular type of heart problem called Heart Failure with Preserved Ejection Fraction, often shortened to HFpEF. In simple terms, this means your heart muscle is still strong and can pump blood out well, but it has trouble relaxing properly to fill with enough blood between beats. Many people with HFpEF are also overweight or obese, and this study wants to understand if losing weight can make a real difference to their health.

The main goal is to see if weight loss can help improve how the heart works – looking at its shape, how effectively it pumps, and how it uses energy. Beyond the heart itself, the study also aims to discover if losing weight can improve a person's general well-being, including their quality of life and their ability to do everyday activities and exercise. This research is important because it could lead to better ways of managing HFpEF for people who are struggling with both conditions.

Participants will be split into two groups by chance (like drawing names from a hat): one group will follow a special diet plan designed to help them lose weight, while the other group will continue with their usual care. Throughout the study, various measurements will be taken to compare the effects between these two groups and understand the potential benefits of weight loss.

Key takeaways

This study explores if weight loss helps people with a specific type of heart failure (HFpEF).
It aims to improve heart function, exercise ability, and quality of life.
Participants will undergo scans and tests over two visits within a few months.
You'll either follow a supervised diet program or continue regular care.
Your involvement could help improve future treatments for HFpEF.

Who may be eligible?

This study is looking for people aged 18 to 85 years old, of any gender. To be considered, you must have been diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF). This means your heart's main pumping chamber should still be able to pump out at least 50% of the blood it contains with each beat. You also need to be overweight or obese, with a Body Mass Index (BMI) of approximately 27.5 or higher.

There are some reasons why you wouldn't be able to join. For example, if you can't have an MRI scan for medical reasons, or if your heart failure is very severe (known as NYHA class IV). You also can't participate if you have other serious heart conditions that might confuse the study results, or if you are pregnant, planning to become pregnant, or breastfeeding. The researchers will also check for any other health issues that might make the study unsafe for you or impact the accuracy of the findings.

Quick self-check

Are you between 18 and 85 years old?
Have you been diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF)?
Is your Body Mass Index (BMI) approximately 27.5 or higher?
Are you able to have an MRI scan?
Are you not currently pregnant, planning to be, or breastfeeding?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be involved for a few months. You'll have two main appointments at the study site, separated by a period of 3 to 6 months. During this time between appointments, some participants will follow a special diet.

During each study visit, you can expect us to take various measurements. This will include filling out questionnaires about your symptoms and how your quality of life is, as well as standard body measurements like your height and weight. You'll also have blood tests, and scans of your heart using both ultrasound (echocardiogram) and MRI. Some exercise will be included during these scans. Finally, you'll do a 6-minute walk test to see how far you can walk in that time.

You'll be randomly assigned to one of two groups: a 'diet' group or a 'control' group. If you're in the control group, you'll continue with your usual medical care. If you're in the diet group, you'll take part in an 8-week weight loss program led by the study team. This involves replacing your regular meals with special meal replacement products like soups, shakes, and porridges, which are designed for safe weight loss. After the 8 weeks, you'll receive guidance on reintroducing regular food and maintaining your weight.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving close medical supervision during a structured weight loss program if you're in the diet group, and contributing to important research that could improve care for others with HFpEF. However, as with any study, there are potential risks, including discomfort from blood tests or scans, or side effects from the diet plan. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
Oxford, United Kingdom· Recruiting

Common questions

What is Heart Failure with Preserved Ejection Fraction (HFpEF)?

HFpEF means your heart muscle is still strong but has difficulty relaxing to fill with enough blood, leading to symptoms like breathlessness.

Will I have to pay for the diet products?

No, if you're in the diet group, the meal replacement products will be provided by the study team.

How long will I be involved in the study?

Your involvement will include two study visits, separated by 3-6 months, with the diet program taking place during that middle period if you're in the diet group.

What is a 'random allocation'?

It means you'll be assigned to either the diet or control group purely by chance, like flipping a coin, so it's fair.

What does 'standard care' mean?

If you're in the control group, 'standard care' means you'll continue with the medical treatments and advice you usually receive from your doctors.

How to find out more

Jiliu Pan, BMBCh

jiliu.pan@cardiov.ox.ac.uk +44(0)1865234591 Official trial record

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