Weight Loss in Elderly Patients With Atrial Fibrillation (LOSE-AF): A Randomised Controlled Trial

Who is this study for? Older patients with atrial fibrillation who are overweight/obese
What treatments are being studied? Meal Replacement Weight Loss Program
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 weight loss programme with meal replacement \& behavioral support can reduce AF-recurrences and improve physical performance 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 meal replacement programme with behavioral support (intervention) or (b) usual care (control) for 32-to-36 weeks. The primary endpoints are AF recurrence and physical performance test (PPT) score. Participants randomised to the study intervention will be referred to a commercial provider (CP) providing the intervention. The co-primary endpoints of AF recurrence \& PPT score will be analysed irrespective of compliance during the scheduled treatment period following an intention-to-treat principle.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• Persistent AF

• Body mass index ≥27 kg/m2

Locations
Other Locations
United Kingdom
Oxford Centre for Magnetic Resonance (OCMR)
RECRUITING
Oxford
Contact Information
Primary
Rohan S Wijesurendra, MBBChirDPhil
rohan.wijesurendra@cardiov.ox.ac.uk
+441865743532
Backup
Marco Spartera, MD DPhil
marco.spartera@cardiov.ox.ac.uk
Time Frame
Start Date: 2018-11-14
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 180
Treatments
Experimental: Meal Replacement Weight Loss Programme
The study intervention will be the referral to a commercial provider (CP) offering a Meal Replacement Weight Loss Programme with behavioural support. 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 counsellors delivering the programme will receive, beyond their routine training and accreditation, specific information related to this study before being allocated patients. The programme conventionally includes the 3 phases (meal replacement phase, transition phase, and weight maintenance phase) but the Consultant will have full discretion to modify and tailor this programme to suit each individual participant.
Active_comparator: 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 at the John Radcliffe Hospital, Oxford) together with supporting written information (i.e. a copy of the booklet 'Facts not fads - Your simple guide to healthy weight loss.')
Related Therapeutic Areas
Sponsors
Leads: University of Oxford

This content was sourced from clinicaltrials.gov