What is the low calorie meal replacement plan studying for heart failure with preserved ejection fraction?

This trial is studying whether a low calorie meal replacement plan can improve heart function, symptoms, and exercise ability in adults with heart failure with preserved ejection fraction (HFpEF), a condition linked to obesity and type 2 diabetes. The University of Leicester is leading this research to find better treatment options for this condition. Participants will follow a diet or receive standard care to compare outcomes.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 years or older with a diagnosis of heart failure with preserved ejection fraction (HFpEF) and obesity may be eligible. Both men and women can participate if they are clinically stable and able to complete a 6-minute walk test. People who are pregnant or have certain heart or lung conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study diet and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any travel costs associated with attending study visits.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID05887271

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

Led by University of Leicester · Updated on 2025-10-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Heart failure with preserved ejection fraction HFpEF is a common and serious condition linked to obesity and type 2 diabetes. It occurs when the heart muscle cannot relax properly to pump blood, causing fluid build-up, breathlessness, and difficulty with physical activity. Treatments are limited, so this study is evaluating whether a low calorie diet can improve heart function, symptoms, and exercise ability in a diverse group of adults with established HFpEF. The study is sponsored by the University of Leicester and involves 63 adult participants. Participants will be randomly assigned to one of two groups one group will follow a low calorie meal replacement plan MRP consisting of 3-4 meals per day totaling about 850 kcal, supported by dietitians and clinicians for 12 weeks. The other group will receive standard care with health advice on weight loss and heart failure exercise guidelines, then after 12 weeks will have the option to try the meal replacement plan. The study will take place across multiple sites and includes a possible extension to repeat the diet after 12 weeks for the control group. During the study, participants will undergo various assessments including a 6-minute walk test to measure exercise capacity, cardiovascular imaging, blood tests, muscle strength evaluations, and questionnaires on heart failure symptoms and quality of life. Activity levels will be tracked using an accelerometer worn for 7 days. Optional interviews will explore participants experiences with dietary changes. The main outcome is the change in distance walked in 6 minutes after 12 weeks, with other measures including heart function, symptoms, physical activity, and muscle health. Safety and health will be closely monitored throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Established clinical diagnosis of heart failure with preserved ejection fraction (EF >45%) confirmed by a cardiologist, heart failure expert, or heart failure nurse
Clinically stable for at least 3 months with no hospital admissions
Obesity defined as BMI ≥30kg/m2 for white European ethnicity or ≥27kg/m2 for Asian, Middle Eastern, or Black ethnicity
Age 18 years or older

You will not qualify if you...

Unable to walk or complete a 6-minute walk test
Unable to follow a low-energy meal replacement plan
Heart failure due to infiltrative cardiomyopathy, genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease, or congenital heart disease
Previous reduced ejection fraction below 40%, unless due to tachycardia-induced cardiomyopathy
Known heritable, idiopathic, or drug-induced pulmonary arterial hypertension
Severe chronic obstructive pulmonary disease with FEV1 less than 1.0L
Severe primary valvular heart disease
Anaemia with hemoglobin less than 100g/L
Severe renal disease with eGFR less than 30 ml/min/1.73 m2
Weight loss greater than 5kg in the past 3 months
Symptomatic gallstones or cholecystitis within the last 3 months
Active substance abuse (drugs or alcohol)
History of bariatric surgery in the last 3 years
Active illness likely to cause weight change
Pregnant women or those considering pregnancy
Participation in another clinical trial affecting diet or weight
History of severe mental illness including eating disorders
Diagnosis of Type 1 diabetes mellitus

Research Team

Sarah L Ayton, MBBS

Emer M Brady, PhD

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