Clinical trial NCT05942287: The Effect of Obesity and Weight Loss in Heart Failure With Reduced Ejection Fraction.
Official title: The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Reduced Ejection Fraction Substudy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Obesity
Overweight
Keywords: heart failure
weight loss
low energy diet
reduced ejection fraction
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2023-07-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at the effects of weight loss in people who have heart failure with reduced ejection fraction (HFpEF) and are overweight or obese.

The main questions it aims to answer are whether weight loss in this group of people improves:

* The heart's shape and how well it pumps blood
* The person's quality of life and how much they can exercise

Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits.

Each study visit may involve measurements including:

Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care.

The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.


Eligibility criteria: Inclusion Criteria:

* Heart failure determined by left ventricular ejection fraction 20-45%
* Body mass index \> 27.5kg/m\^2

Exclusion Criteria:

* Contraindications to magnetic resonance imaging
* NYHA class IV
* Pregnancy, planned pregnancy or lactating
* Significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease
* Any other conditions which may potentially compromise the safety or scientific validity of the study

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: Change from baseline at 3-6 months
Secondary outcomes:
measure: Body weight
timeFrame: Change from baseline at 3-6 months
measure: Six minute walk distance
timeFrame: Change from baseline at 3-6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Change from baseline at 3-6 months
measure: N-terminal pro brain natriuretic peptide (NTproBNP)
timeFrame: Change from baseline at 3-6 months
Other outcomes:
measure: Left ventricular mass
timeFrame: Change from baseline at 3-6 months
measure: Left atrial volume
timeFrame: Change from baseline at 3-6 months
Locations:
city: Jersey
country: Jersey
facility: Jersey General Hospital
city: Oxford
country: United Kingdom
facility: Jenny Rayner
Study officials:
affiliation: University of Oxford
name: Oliver J Rider, DPhil
role: PRINCIPAL_INVESTIGATOR
References: