A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
NCT ID: NCT05887271
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
63 participants
INTERVENTIONAL
2023-12-05
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low calorie meal replacement plan (MRP) arm
The MRP comprises of 3-4 meals a day (850kcal/day) supplied by Counterweight. Participants will be supported by professional research dieticians, and a study clinician. Participant health and medications will be monitored throughout the study.
Offered to the comparator arm after 12 weeks as a control participant.
Low calorie meal replacement plan
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
CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue. Cardiac 31P magnetic resonance spectroscopy imaging to assess cardiac muscle energetics according to a standardised operating procedure
Transthoracic echocardiography
Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function
Blood test
Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.
Electrocardiogram
An ECG will be obtained to assess for baseline rhythm.
Accelerometery
Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days.
6 minute walk test (6MWT)
Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's).
Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)
Skeletal muscle strength will be measured using a cybex dynamometer.
Assessment of quality of life and heart failure symptoms
Quality of life and HF symptoms will be assessed using the Minnesota Living with Heart Failure (MLWHF) 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
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. It is a robust tool for diagnosis of sarcopenia and prediction poor physical function, with excellent specificity in multimorbid individuals.
Assessment of frailty
Frailty will be assessed using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment which assesses multiple domains of frailty including functional independence, social support, cognition, medication use, and mood.
Qualitative interview
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. Participants who complete or drop out will be eligible. Inclusion of participants in the control arm will allow us to compare the experiences of MRP versus health coaching and detect any specific issues people face when trying to introduce lifestyle changes themselves.
Wait list control arm: Guideline driven care with attention control arm followed by optional MRP
Dietary advice to participants will be given in line with NICE guidelines for cardiovascular risk modification. Heart failure specific advice on exercise will be given in line with guidelines. After 12 weeks as a control participant, these individuals will then have the option to receive the meal replacement plan and repeat assessments after a further 12 weeks.
Low calorie meal replacement plan
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
CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue. Cardiac 31P magnetic resonance spectroscopy imaging to assess cardiac muscle energetics according to a standardised operating procedure
Transthoracic echocardiography
Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function
Blood test
Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.
Electrocardiogram
An ECG will be obtained to assess for baseline rhythm.
Accelerometery
Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days.
6 minute walk test (6MWT)
Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's).
Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)
Skeletal muscle strength will be measured using a cybex dynamometer.
Assessment of quality of life and heart failure symptoms
Quality of life and HF symptoms will be assessed using the Minnesota Living with Heart Failure (MLWHF) 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
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. It is a robust tool for diagnosis of sarcopenia and prediction poor physical function, with excellent specificity in multimorbid individuals.
Assessment of frailty
Frailty will be assessed using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment which assesses multiple domains of frailty including functional independence, social support, cognition, medication use, and mood.
Qualitative interview
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. Participants who complete or drop out will be eligible. Inclusion of participants in the control arm will allow us to compare the experiences of MRP versus health coaching and detect any specific issues people face when trying to introduce lifestyle changes themselves.
Interventions
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Low calorie meal replacement plan
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
CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue. Cardiac 31P magnetic resonance spectroscopy imaging to assess cardiac muscle energetics according to a standardised operating procedure
Transthoracic echocardiography
Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function
Blood test
Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.
Electrocardiogram
An ECG will be obtained to assess for baseline rhythm.
Accelerometery
Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days.
6 minute walk test (6MWT)
Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's).
Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)
Skeletal muscle strength will be measured using a cybex dynamometer.
Assessment of quality of life and heart failure symptoms
Quality of life and HF symptoms will be assessed using the Minnesota Living with Heart Failure (MLWHF) 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
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. It is a robust tool for diagnosis of sarcopenia and prediction poor physical function, with excellent specificity in multimorbid individuals.
Assessment of frailty
Frailty will be assessed using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment which assesses multiple domains of frailty including functional independence, social support, cognition, medication use, and mood.
Qualitative interview
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. Participants who complete or drop out will be eligible. Inclusion of participants in the control arm will allow us to compare the experiences of MRP versus health coaching and detect any specific issues people face when trying to introduce lifestyle changes themselves.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically stable for ≥ 3 months (no admissions to hospital)
3. Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity)
4. Age ≥18
Exclusion Criteria
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. Recovered EF (previous EF \< 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF/Aflutter).
5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
6. Severe chronic obstructive pulmonary disease (FEV1\< 1.0L)
7. Severe primary valvular heart disease
8. Anaemia (Hb\<100g/L)
9. Severe renal disease (eGFR \< 30 ml/min/1.73 m2)
10. Weight loss \> 5kg in preceding 3 months.
11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months
12. Active substance abuse (drugs or alcohol)
13. History of bariatric surgery in the last 3 years
14. Active illness likely to cause change in weight
15. Women who are pregnant or are considering pregnancy
16. People currently participating in another clinical research trial that is likely to affect diet or weight change.
17. History of a severe mental illness including an eating disorder
17\. Individuals with a diagnosis of Type 1 diabetes mellitus.
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
University of Manchester
OTHER
University of Leeds
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Gerry P McCann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
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University of Leicester, Glenfield Hospital, Groby Road
Leicester, Leicestershire, United Kingdom
University of Manchester, Wythenshawe Hospital, Southmoor Road
Manchester, , United Kingdom
University of Oxford, John Radcliffe Hospital, Headley Way
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Bilak JM, Squire I, Wormleighton JV, Brown RL, Hadjiconstantinou M, Robertson N, Davies MJ, Yates T, Asad M, Levelt E, Pan J, Rider O, Soltani F, Miller C, Gulsin GS, Brady EM, McCann GP. The Protocol for the Multi-Ethnic, multi-centre raNdomised controlled trial of a low-energy Diet for improving functional status in heart failure with Preserved ejection fraction (AMEND Preserved). BMJ Open. 2025 Jan 28;15(1):e094722. doi: 10.1136/bmjopen-2024-094722.
Other Identifiers
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0861
Identifier Type: -
Identifier Source: org_study_id
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