Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Joanna Bilak
jmb99@leicester.ac.uk


Prof Gerry McCann
gpm12@leicester.ac.uk


Study Location:

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Be Part of Research - Trial Details - AMEND Preserved

AMEND Preserved

Recruiting

Open to: Female / Male

Age: 18 Years - 100 Years

Medical Conditions

Other forms of heart disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle is unable to relax sufficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data using low energy diets in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. In this study, we will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. We will invite 102 adults and allocate them by chance (much like tossing a coin) into two groups: either a 12-week diet or health advice on how to lose weight. We will see if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. We will get participants’ views on changing their diet and how this has impacted on their symptoms. This will help us plan treatments in the future to get maximum benefits, and individualize support to patients from different cultural backgrounds.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

19 Sep 2023 30 Sep 2025

Interventional

Interventional type: Dietary;



You can take part if:



You may not be able to take part if:


1. Inability to walk/undertake 6MWT 2. Inability to follow a low-energy MRP 3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease 4. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension 5. Severe chronic obstructive pulmonary disease (FEV1< 1.0L) 6. Severe primary valvular heart disease 7. Anaemia (Hb< 100g/L) 8. Severe renal disease (eGFR < 30 ml/min/1.73 m2) 9. Weight loss > 5kg in preceding 3 months. 10. Known gallstones/previous biliary colic


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • New Cross Hospital
    Wolverhampton Road
    heath Town
    Wolverhampton
    West Midlands
    WV10 0QP
  • University Hospital (coventry)
    Clifford Bridge Road
    Coventry
    West Midlands
    CV2 2DX
  • Renamed University Hospital
    Beckett Street
    Leeds
    West Yorkshire
    LS9 7TF
  • Kettering General Hospital
    Rothwell Rd
    Kettering
    Northamptonshire
    NN16 8UZ
  • Leeds General Infirmary
    Great George Street
    Leeds
    West Yorkshire
    LS1 3EX
  • Glenfield Hospital
    Groby Road
    Leicester
    Leicestershire
    LE3 9QP

Joanna Bilak
jmb99@leicester.ac.uk


Prof Gerry McCann
gpm12@leicester.ac.uk



The study is sponsored by University of Leicester and funded by THE BRITISH SOCIETY FOR HEART FAILURE .




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for Trial ID: CPMS 54184

Last updated 25 April 2025

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