RecruitingNot ApplicableNCT05942287

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

The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Reduced Ejection Fraction Substudy


Sponsor

University of Oxford

Enrollment

110 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (HFpEF) and are overweight or obese. The main questions it aims to answer are whether weight loss in this group of people improves: * The heart's shape and how well it pumps blood * The person's quality of life and how much they can exercise Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits. Each study visit may involve measurements including: Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care. The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether obesity and weight loss affect heart function in people with heart failure with reduced ejection fraction (HFrEF) — a type of heart failure where the heart muscle does not pump enough blood. **You may be eligible if...** - You have been diagnosed with heart failure with a reduced pumping function (ejection fraction between 20–45%) - Your BMI is above 27.5 kg/m² (overweight or obese) - You are stable enough to undergo MRI scanning **You may NOT be eligible if...** - You have a metal implant or another reason you cannot have an MRI (such as a pacemaker) - You have severe heart failure (NYHA class IV — unable to carry out any physical activity without discomfort) - You are pregnant, planning to become pregnant, or breastfeeding - You have significant valve disease, recent heart attack, or infiltrative heart disease (e.g., amyloidosis) - You have had a heart transplant or have a ventricular assist device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiet intervention

The diet intervention delivers a weight loss program. The main component is a total diet replacement low energy diet. The intervention includes a gradual food reintroduction phase and maintenance strategies.


Locations(2)

Jersey General Hospital

Jersey, Jersey, Jersey

Jenny Rayner

Oxford, United Kingdom

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NCT05942287


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