About this trial

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 unable to relax efficiently 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 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. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.

Eligibility criteria

Qualifiers

Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse

Clinically stable for ≥ 3 months (no admissions to hospital)

Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity)

Age ≥18

Disqualifiers

Inability to walk/undertake 6-minute walk test

Inability to follow a low-energy MRP

HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease.

Recovered EF (previous EF < 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF/Aflutter).

Trial design

Treatments tested in this trial

  • Low calorie meal replacement plan
  • Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy
  • Transthoracic echocardiography
  • Blood test
  • Electrocardiogram
  • Accelerometery
  • 6 minute walk test (6MWT)
  • Skeletal muscle strength using handgrip strength
  • Assessment of quality of life and heart failure symptoms
  • Assessment of sarcopenia
  • Assessment of frailty
  • Qualitative interview

Treatment groups

63 Participants
are divided into 2 treatment groups

Locations

3
University of Leicester, Glenfield Hospital, Groby RoadLE3 9QP, LeicesterLeicestershire, United Kingdom
University of Manchester, Wythenshawe Hospital, Southmoor RoadM23 9LT, Manchester United Kingdom
University of Oxford, John Radcliffe Hospital, Headley WayOX3 9DU, Oxford United Kingdom

Sponsors and collaborators

University of Leicester

Lead sponsor

University of Oxford

Collaborator

University of Manchester

Collaborator

University of Leeds

Collaborator