LOSE-AF: Can Weight Loss Help Patients With Atrial Fibrillation?

Summary

Background Atrial fibrillation (AF) affects over 1 million individuals in the UK and results in costs of over £450 million per year to the National Health Service (NHS). Current rhythm control strategies are limited by high recurrences of AF. New strategies tackling more upstream pathophysiological mechanisms are most needed. The incidence and prevalence of AF markedly increase with age, whilst obesity is the strongest modifiable risk factor for AF. Preliminary data in relatively young patients suggest that weight loss programmes may reduce AF burden and improve AF-related symptoms. Such programmes could be a widely-applicable and cost-effective option in AF management if they are also effective in elderly patients with AF, particularly if they also improve physical performance.

Aim The aim of this study is to investigate whether, in older overweight/obese AF patients, referral to a dietary weight loss programme and behavioral support programme can reduce AF-related symptoms compared to usual care.

Study design Parallel-group, open-label, multi-centre randomised controlled trial. Elderly individuals (60-85 years) with persistent AF and elevated body mass index (BMI; ≥ 27 kg/m2) will be recruited. Participants will be randomly allocated (1:1) to (a) referral to a dietary weight loss and behavioral support programme (intervention) or (b) usual care (control) for 32-to-36 weeks. The primary endpoint is AF-related symptoms determined using the AF Severity Scale (AFSS) Symptoms Severity score. Participants randomised to the study intervention will be referred to a commercial provider (CP) providing the intervention. The primary endpoint will be analysed irrespective of compliance during the scheduled treatment period following an intention-to-treat principle.

Conditions

• Atrial Fibrillation
• Overweight and Obesity

Interventions

OTHER

Meal Replacement Weight Loss Programme

The study intervention will be the referral to a commercial provider (CP) offering a Meal Replacement Programme. Briefly, participants will be referred to a nominated CP local counsellor who will set regular appointments during a period of 32-to-36 weeks to provide behavioural support, weight monitoring, and deliver formula meals. All counselors delivering the programme will receive, beyond their routine training and accreditation, specific information related to this study before being allocated patients.

OTHER

Usual Care

Participants randomised to the control group will receive best usual care, consisting of a one-off face-to-face consultation on weight loss with a nurse at baseline (\~15 min), together with supporting written information.

Sponsors & Collaborators

• University of Oxford

  lead OTHER

Principal Investigators

• Rohan Wijesurendra, MB BChir MA MSc DPhil · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-14

Primary Completion

2025-04-01

Completion

2025-04-01

Countries

• United Kingdom

Study Locations