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

    rohan.wijesurendra@cardiov.ox.ac.uk

  • 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