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Heart Failure With Preserved Ejection FractionPhase 2/3AMENDNCT05887271

A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction

A Phase 2/3 study testing Low calorie meal replacement plan, Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy and Transthoracic echocardiography in people with Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, run by University of Leicester at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low calorie meal replacement plan, Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy and Transthoracic echocardiography
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesUnited Kingdom
Study dates
5 Dec 2023to 17 Jun 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
  • Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
  • Severe chronic obstructive pulmonary disease (FEV1< 1.0L)
Show all 18Show fewer
  • Severe primary valvular heart disease
  • Anaemia (Hb<100g/L)
  • Severe renal disease (eGFR < 30 ml/min/1.73 m2)
  • Weight loss > 5kg in preceding 3 months.
  • Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months
  • Active substance abuse (drugs or alcohol)
  • History of bariatric surgery in the last 3 years
  • Active illness likely to cause change in weight
  • Women who are pregnant or are considering pregnancy
  • People currently participating in another clinical research trial that is likely to affect diet or weight change.
  • History of a severe mental illness including an eating disorder
  • 17. Individuals with a diagnosis of Type 1 diabetes mellitus.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • University of Leicester, Glenfield Hospital, Groby Road

    Leicester, Leicestershire, LE3 9QP

  • University of Manchester, Wythenshawe Hospital, Southmoor Road

    Manchester, M23 9LT

  • University of Oxford, John Radcliffe Hospital, Headley Way

    Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: A 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)

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.

Read the detailed description

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.

Being tested
Low calorie meal replacement plan, Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy, Transthoracic echocardiography, Blood test, Electrocardiogram
Keywords
Heart failure with preserved ejection fraction, Diastolic heart failure, Type 2 diabetes mellitus, Obesity, Meal replacement plan, Cardiac magnetic resonance imaging, Exercise intolerance, Diabetes remission
Medical subject headings
Heart Failure, Diastolic, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low calorie meal replacement planDrug

    Also called Diet

    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 spectroscopyDiagnostic test

    Also called CMR

    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, aortic distensibility 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. Additional imaging will be undertaken for 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 echocardiographyDiagnostic test

    Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling, exclusion of valvular abnormalities, assessment of LV size and function

  • Blood testDiagnostic test

    Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.

  • ElectrocardiogramDiagnostic test

    Also called ECG

    An ECG will be obtained to assess for baseline rhythm.

  • AccelerometeryDiagnostic 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 strengthDiagnostic test

    Skeletal muscle strength will be measured using hand grip strength

  • Assessment of quality of life and heart failure symptomsOther

    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 sarcopeniaOther

    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 frailtyOther

    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 interviewOther

    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.

Study groups in NCT05887271
Study groupRoleWhat they receive
Low calorie meal replacement plan (MRP) armExperimentalThe 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.
Receives: Drug: Low calorie meal replacement plan; Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Blood test; Diagnostic Test: Electrocardiogram; Diagnostic Test: Accelerometery; Diagnostic Test: 6 minute walk test (6MWT); Diagnostic Test: Skeletal muscle strength using handgrip strength; Other: Assessment of quality of life and heart failure symptoms; Other: Assessment of sarcopenia; Other: Assessment of frailty; Other: Qualitative interview
Wait list control arm: Guideline driven care with attention control arm followed by optional MRPActive comparatorDietary 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.
Receives: Drug: Low calorie meal replacement plan; Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Blood test; Diagnostic Test: Electrocardiogram; Diagnostic Test: Accelerometery; Diagnostic Test: 6 minute walk test (6MWT); Diagnostic Test: Skeletal muscle strength using handgrip strength; Other: Assessment of quality of life and heart failure symptoms; Other: Assessment of sarcopenia; Other: Assessment of frailty; Other: Qualitative interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the distance walked during 6 minute walk test (6MWT)

    The primary outcome measure is a change in the distance walked on 6MWT measured in meters

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

Secondary outcomes (8)

  1. Beneficial reverse cardiovascular remodelling

    CMR-derived measures of cardiovascular remodelling defined as left ventricular mass/volume ratio

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

  2. Change in physical activity levels

    Improvement in physical activity will be determined by change in daily activity as determined accelerometery

    Measured: Assessed at baseline and 12 weeks

  3. Change in upper limb muscle power

    Change in muscle power will be determined by handgrip strength

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

  4. Improvement in exercise tolerance

    This will be assessed by change in Borg dyspnoea scale during 6MWT

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

  5. Improvement in symptoms of heart failure

    This will be assessed by a change in the Kansas City Cardiomyopathy Questionnaire score

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

  6. Change in sarcopenia

    This will be assessed by a change in the SARC-F questionnaire score

    Measured: Assessed at baseline and 12 weeks, optional repeat at 24 weeks

  7. Exploratory outcome: Improving skeletal and cardiac energetics

    31P magnetic resonance spectroscopy: Cardiac PCr/ATP

    Measured: Baseline and 12 weeks

  8. Exploratory outcome: change in fibroinflammatory biomarker panel

    Exploratory analysis of the fibroinflammatory biomarker panel to identify potential pathways involved in the development, progression or outcomes of HFpEF.

    Measured: This will be evaluated at baseline and at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start5 Dec 2023
  3. Primary completion17 Jun 2026
  4. Study completion17 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-centre, prospective, open-label blinded end-point randomised wait-list controlled trial of low-energy Meal Replacement Plan (MRP) versus guideline-driven care, and a nested qualitative sub-study.
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887271
Sponsor's protocol ID
0861
Acronym
AMEND
Status last verified
Jun 2026
First submitted
2 May 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers.

Publications

  • 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.

    PubMed 39880434

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Low calorie meal replacement plan, Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy and Transthoracic echocardiography in people with Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, run by University of Leicester at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the distance walked during 6 minute walk test (6MWT) (time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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