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

Launched by UNIVERSITY OF LEICESTER · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a low-energy diet can help improve heart function and physical abilities in people with heart failure with preserved ejection fraction (HFpEF). HFpEF is a condition where the heart has trouble relaxing and pumping blood effectively, often affecting those who are obese or have type 2 diabetes. The trial will involve 102 adults who will be randomly divided into two groups: one group will follow a specific diet for 12 weeks, while the other group will receive general health advice on weight loss. The goal is to see if losing weight can lead to better heart function, improved symptoms, and increased ability to exercise.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of HFpEF. They should also be clinically stable for at least three months and have a body mass index (BMI) indicating obesity. Participants should expect to follow a low-energy diet and may also take part in interviews to share their thoughts on how the diet changes affect their symptoms. This information will help doctors understand how to better support patients from different backgrounds in the future. It's important to note that certain health conditions may exclude some individuals from participating, such as severe lung disease or significant heart issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 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:
• • 1. Inability to walk/undertake 6-minute walk test
• • 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 disease95
• • 4. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
• • 5. Severe chronic obstructive pulmonary disease (FEV1\< 1.0L)
• • 6. Severe primary valvular heart disease
• • 7. Anaemia (Hb\<100g/L)
• • 8. Severe renal disease (eGFR \< 30 ml/min/1.73 m2)
• • 9. Weight loss \> 5kg in preceding 3 months.
• • 10. Known gallstones/previous biliary colic