LOSE-AF: can weight loss help patients with atrial fibrillation?
Research type
Research Study
Full title
Weight Loss in Elderly Patients with Atrial Fibrillation (LOSE-AF): A Randomised Controlled Study
IRAS ID
242939
Contact name
Rohan Wijesurendra
Contact email
Sponsor organisation
RGEA (Research Governance, Ethics & Assurance)
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Background
Atrial fibrillation (AF) is the most common heart rhythm abnormality. It affects over 1 million individuals in the UK and results in costs of over £450 million per year to the National Health Service (NHS). The risk of AF strongly increases as people get older and as they gain weight. Although we cannot do anything about aging, we can try and reduce obesity, which is another very important risk factor for AF.
AF often leads to unpleasant symptoms (dizziness, shortness of breath, chest pain). Patients with AF frequently experience reduced quality of life and require repeated hospitalizations. Current treatments aiming at reducing symptoms have many side effects and many times AF returns as severe as before treatment (i.e. AF recurrences).
Total Diet Replacement (TDR) programmes are promising and highly effective strategies for weight loss, combining diet and behavioural support. Preliminary data suggest that weight loss programmes may reduce the re-occurrence of AF. Such programmes could be a widely applicable, non-invasive, and cost-effective options in AF management, with the potential of improving physical performance as well.
Aim
The aim of this study is to investigate whether, in older overweight/obese AF patients, referral to a TDR programme can reduce AF-recurrences and improve physical performance.
Study design
This is a parallel-group, open-label, randomised controlled study. Elderly individuals (65-85 years) with symptomatic AF and elevated BMI (≥ 27 kg/m2) will be recruited. Participants will be randomised (1:1) to (a) TDR programme for a total of 8 months (intervention) or (b) usual care; i.e., nurse-based consultation and supporting written material (control). All participants will undergo a baseline visit (prior to randomisation) and a follow-up visit at 8 months. Both study visits will include physical performance test, MR scan, AF symptom questionnaire, quality of life (QoL), Patient health-Resource Use Questionnaire (PRUQ), and bloods. Additionally, ECG monitoring, cardiac CT scan, and patient-reported outcome measures (PROMs) will also be acquired at the 8-months visit. Finally, at 4 months patients will be asked to complete ad interim questionnaires (QoL, PRUQ, PROMs) posted at their home and returned to study investigators.
Primary endpoints (AF recurrences & PPT score) will be analysed irrespective of compliance during the scheduled treatment period following an intention-to-treat principle.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0197
Date of REC Opinion
18 Jul 2018
REC opinion
Further Information Favourable Opinion