RecruitingNAINTERVENTIONAL

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

This research is looking into how weight loss might help people who have a condition called heart failure with reduced ejection fraction (sometimes shortened to HFpEF) and are also overweight or obese. The main goal is to see if losing weight can make their heart work better and improve their overall quality of life and ability to exercise. Participants will be placed into one of two groups by chance: a diet group or a standard care group. The diet group will follow a special meal replacement plan, supervised by the study team, to help them lose weight. The study involves a couple of visits over a few months, with various health checks like blood tests and heart scans.

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

110

Start

24 May 2023

Estimated completion

31 Dec 2026

Heart Failure Heart Failure With Reduced Ejection Fraction Obesity Overweight

What is this study about?

This study is about a common heart condition called heart failure with reduced ejection fraction (HFpEF). This means your heart muscle isn't pumping blood as effectively as it should. We know that being overweight or obese can put extra strain on your heart. This research wants to find out if losing weight can actually help improve the condition for people with HFpEF.

Specifically, the study aims to answer two important questions: Can losing weight improve how well your heart pumps blood and even change its shape for the better? And, can it also boost your quality of life, making it easier to do daily activities and exercise?

By understanding these effects, doctors can get closer to finding better ways to help people living with heart failure. If weight loss proves to be a very helpful treatment, it could make a real difference to many lives.

Key takeaways

This study explores if weight loss helps people with a specific type of heart failure.
It aims to see if losing weight improves heart function and quality of life.
Participants will either follow a special diet or continue their usual care.
Participation involves two visits over 3-6 months with various health checks.
The diet program includes meal replacements for 8 weeks, then guided reintroduction of food.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old. You must have a specific type of heart failure where your heart's main pumping chamber doesn't squeeze as strongly as it should. Alongside this, you also need to be overweight, which is usually measured by something called your Body Mass Index (BMI).

There are also some reasons why you might not be able to join. For example, if you are pregnant, planning to become pregnant, or breastfeeding. Also, if you have certain other serious heart problems or conditions that might make it unsafe for you to participate, or if you can't have an MRI scan for medical reasons, you wouldn't be able 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.

Are you between 18 and 85 years old?
Do you have heart failure where your heart's main pumping chamber doesn't squeeze well (HFpEF)?
Are you currently overweight (with a BMI above 27.5)?
Are you NOT pregnant, planning to get pregnant, or breastfeeding?
Do you NOT have medical reasons preventing you from having an MRI scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have two main study visits, separated by about 3 to 6 months. During these visits, the study team will take your height and weight, ask you to fill in some questionnaires about your symptoms and how you're feeling, take blood samples, and do ultrasound and MRI scans of your heart. You'll also do a 6-minute walking test to see how far you can walk comfortably.

Between these two visits, you'll be put into one of two groups by chance – like drawing lots. One group will continue with their usual medical care. The other group will follow a special diet plan supervised by the study team. This diet involves replacing your regular meals with specific meal replacement products (like soups, shakes, and porridges) for 8 weeks, followed by a period where you're guided on reintroducing regular food and keeping the weight off. The total duration of your active involvement in the study would be between 3 to 6 months.

Potential risks and benefits

Taking part in this study could offer some benefits, such as potentially improving your heart health and quality of life if you are in the diet group. You'll also receive close monitoring and health assessments. As with any study, there are potential risks, such as side effects from the diet program, or the general discomfort of tests like blood draws or MRI scans. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Jersey General Hospital
Unverified
Jersey, Jersey· Recruiting
Jenny Rayner
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is 'heart failure with reduced ejection fraction'?

It's a type of heart failure where your heart's main pumping chamber doesn't squeeze as strongly as it should, making it harder to pump blood out to your body.

Will I have to pay for the diet products?

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

How long does each study visit take?

The study description doesn't specify the exact length of each visit, but they will involve multiple tests like blood samples, scans, and questionnaires.

Can I choose which group I'm in?

No, participants are put into either the diet group or the standard care group by chance, like a lottery system, to ensure the study is fair.

What if I get pregnant during the study?

If you are pregnant, planning to become pregnant, or breastfeeding, you would not be able to participate in this study.

How to find out more

Jenny Rayner, DPhil

jenny.rayner@cardiov.ox.ac.uk +441865221172 Official trial record

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