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
- Low calorie meal replacement plan (drug), Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy (diagnostic test), Transthoracic echocardiography (diagnostic test), Blood test (diagnostic test)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Low calorie meal replacement plan — drug: Meal replacement diet containing \~850 kcal/day (40% protein, 50% carbohydrate, 10% fat) supplied by Counterweight® (www.counterweight.org).The meal replacement plan will comprise of 3-4 meal packs/day (to equate to 850 kcal) with sweet and savoury options, and an allowance of 100ml semi-skimmed milk or a non-dairy alternative. · Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy — diagnostic test: CMR scanning performed on a 3T MRI scanner. · Transthoracic echocardiography — diagnostic test: Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling, exclusion of valvular abnormalities, assessment of LV size and function · Blood test — diagnostic test: Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers. · Electrocardiogram — diagnostic test: An ECG will be obtained to assess for baseline rhythm. · Accelerometery — diagnostic test: Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days. · 6 minute walk test (6MWT) — diagnostic test: Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's). · Skeletal muscle strength using handgrip strength — diagnostic test: Skeletal muscle strength will be measured using hand grip strength · Assessment of quality of life and heart failure symptoms — other: Quality of life and HF symptoms will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire, which is used as a standardised measure of self-reported health status, and HF symptoms and is considered to have a good discriminatory power and validity · Assessment of sarcopenia — other: Participants will be assessed for presence of sarcopenia using the Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls (SARC-F) questionnaire. · Assessment of frailty — other: Frailty will be assessed using the Edmonton Frail Scale (EFS). · Qualitative interview — other: Participants in the MRP and control groups will be invited to attend a focused semi-structured, 1-2-1 interview aimed to elicit barriers and enablers to the MRP and describe their perspective on the relationship between healthy eating and health interview during the 12-week visit.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 66
- Started
- 2023-12-05
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with preserved ejection fraction
- • Phase2/Phase3 - 66 participants
- • Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure with preserved ejection fraction
Where?
- • Leicester - University of Leicester, Glenfield Hospital, Groby Road
- • Manchester - University of Manchester, Wythenshawe Hospital, Southmoor Road
- • Oxford - University of Oxford, John Radcliffe Hospital, Headley Way
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Heart failure (HF) with preserved ejection fraction (HFpEF) is a heterogenous syndrome, typified by severe exercise intolerance and with limited treatment options. Weight loss achieved through a low energy meal-replacement plan (MRP) has been shown to lead to reversal of cardiovascular remodelling in ethnically diverse asymptomatic adults with pre-HFpEF and HFpEF. This trial will translate this experience with the pragmatic low energy MRP into a symptomatic, multi-ethnic cohort of obese HFpEF, across four sites (Leicester, Manchester, Leeds and Oxford) to assess its efficacy in improving exercise intolerance, symptoms, quality of life, cardiovascular remodelling, and skeletal myopathy.
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 and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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
Who cannot take part
- ✗Inability to walk/undertake 6-minute walk test
- ✗Inability to follow a low-energy MRP
- ✗HFpEF due to infiltrative cardiomyopathy (heart amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy,...
- ✗Recovered EF (previous EF \< 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg...
- ✗Known heritable, idiopathic or drug-induced lung arterial hypertension
See the full criteria
Where Is This Study? (3 UK sites)
University of Leicester, Glenfield Hospital, Groby Road
Leicester LE3 9QP, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351University of Manchester, Wythenshawe Hospital, Southmoor Road
Manchester M23 9LT, United Kingdom
University of Oxford, John Radcliffe Hospital, Headley Way
Oxford OX3 9DU, United Kingdom