At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Diet intervention (other)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Diet intervention — other: The diet intervention delivers a weight loss program.
- Patient visit burden
- "The person's quality of life and how much they can exercise Participants will attend 2 study visits, separated by 3-6 months." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 120
- Started
- 2023-01-20
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with preserved ejection fraction
- • NA - 120 participants
- • This study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (HFpEF) and are overweight or obese
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with heart failure with preserved ejection fraction
Where?
- • Oxford - Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study looks at the effects of weight loss in people who have heart failure with preserved 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: 1. The heart's shape, how well it pumps blood and how well it uses fuels 2. 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 will 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 * Exercise components during the scans * 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.
More detail
An interim analysis is planned at 60 recruits to review the recruitment target.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
What the study is looking for
- ✓Heart failure with preserved ejection fraction (HFpEF)
- ✓Left ventricular ejection fraction (LVEF) =/\> 50%
- ✓Body Mass Index (BMI) approximately =/\> 27.5 kg/m\^2
Who cannot take part
- ✗Contraindications to magnetic resonance imaging
- ✗NYHA class IV
- ✗Significant valvular, ischemic, infiltrative or other potentially confounding heart disease
- ✗Pregnancy, planned pregnancy or lactating
- ✗Any other conditions which may potentially compromise the safety or scientific validity of the study
See the full criteria
Where Is This Study? (1 UK site)
Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
How to Get in Touch
Jiliu Pan, BMBCh
Sponsor contactCONTACT
Jenny Rayner, DPhil
Sponsor contactCONTACT