The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction

Официальное название

The Effects of Obesity and Weight Loss in Heart Failure: Imaging the Obesity Paradox Using Magnetic Resonance Imaging and Spectroscopy - Heart Failure With Preserved Ejection Fraction Substudy

Обзор

This study looks at the effects of weight loss in people who have heart failure with preserved 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: 1. The heart's shape, how well it pumps blood and how well it uses fuels 2. 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 will 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 * Exercise components during the scans * 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.

Подробное описание

An interim analysis is planned at 60 recruits to review the recruitment target.

Вмешательства

• Другое Diet intervention
  The diet intervention delivers a weight loss program. The main component is a total diet replacement low energy diet. The intervention includes a gradual food reintroduction phase and maintenance strategies.

Первичные конечные точки

• Left atrial volume [Срок оценки: Change from baseline at 3-6 months]

Вторичные конечные точки (4)

• Body weight [Срок оценки: Change from baseline at 3-6 months]
• Six minute walk distance [Срок оценки: Change from baseline at 3-6 months]
• N-terminal pro brain natriuretic peptide (NT pro BNP) [Срок оценки: Change from baseline at 3-6 months]
• Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: Change from baseline at 3-6 months]

Критерии участия

Критерии включения

• Heart failure with preserved ejection fraction (HFpEF)
• Left ventricular ejection fraction (LVEF) =/> 50%
• Body Mass Index (BMI) approximately =/> 27.5 kg/m\^2

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital — Oxford

Идентификаторы

NCT: NCT05878912 · 161729 (C) · 15/SC/0004 · FS/CRTF/22/24293

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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