NCT Number: NCT05887271
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
University of Leicester, Glenfield Hospital, Groby Road, Leicester, Leicestershire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Diet
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.
Other names: CMR
Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling, exclusion of valvular abnormalities, assessment of LV size and function
Collection of blood samples from each participant to characterise the participant's health status and fibroinflammatory markers.
An ECG will be obtained to assess for baseline rhythm.
Other names: ECG
Accelerometer (GeneActiv) measured daily activity levels continuously for 7 consecutive days.
Supervised 6MWT will be performed with symptom assessment using dyspnoea scale (Borg's).
Skeletal muscle strength will be measured using hand grip strength
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
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.
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.
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.
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
The primary outcome measure is a change in the distance walked on 6MWT measured in meters
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
CMR-derived measures of cardiovascular remodelling defined as left ventricular mass/volume ratio
Time frame: Assessed at baseline and 12 weeks
Improvement in physical activity will be determined by change in daily activity as determined accelerometery
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
Change in muscle power will be determined by handgrip strength
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
This will be assessed by change in Borg dyspnoea scale during 6MWT
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
This will be assessed by a change in the Kansas City Cardiomyopathy Questionnaire score
Time frame: Assessed at baseline and 12 weeks, optional repeat at 24 weeks
This will be assessed by a change in the SARC-F questionnaire score
Time frame: Baseline and 12 weeks
31P magnetic resonance spectroscopy: Cardiac PCr/ATP
Time frame: This will be evaluated at baseline and at 12 weeks
Exploratory analysis of the fibroinflammatory biomarker panel to identify potential pathways involved in the development, progression or outcomes of HFpEF.
University of Leicester
Other
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)
Acronym: AMEND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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