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

NCT03713775 | Completed

• 2 other identifiers: PID13511-SP001-AC002242939
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation symptoms severity (0-35)

  Toronto AF Severity Scale (AFSS) score (points) - This is a validated questionnaire assessing AF symptom severity (range, 0 no symptoms to 35 severe symptomatology). Reference: Dorian P, Jung W, Newman D, et al. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol 2000;36:1303-9.

  8 months

Secondary Outcomes (16)

• Atrial fibrillation burden

  8 months

• Atrial fibrillation symptoms burden (3.25-30)

  4 & 8 months

• Atrial fibrillation symptoms severity (0-35)

  4 months

• Quality of Life (QoL) by EuroQoL EQ-5D-5L utility score

  4 & 8 months

• Patient Reported Outcome Measures (PROMs)

  4 & 8 months

Study Arms (2)

Meal Replacement Weight Loss Programme

EXPERIMENTAL

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.

Other: Meal Replacement Weight Loss Programme

Usual Care

ACTIVE COMPARATOR

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.')

Other: Usual Care

Interventions

Meal Replacement Weight Loss Programme OTHER

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.

Meal Replacement Weight Loss Programme

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent AF
• Body mass index ≥27 kg/m2

You may not qualify if:

• Planned catheter ablation for AF within 8 months
• Learning difficulties or unable to understand English
• Participation in another research trial involving an investigational product or weight loss programme in the prior 3 months
• Current treatment with anti-obesity drugs
• Uncontrolled endocrine disorders
• Diabetes requiring insulin
• Active gout or history of recurrent gout
• Ongoing gallbladder disease
• Serious underlying medical or psychiatric disorder; e.g., known cancer or any other significant disease affecting short-term life expectancy; severe valvular disease, myocardial infarction or stroke within the previous 6 months; severe heart failure; eating disorder or purging behaviour; severe psychotic disorder requiring hospitalisation or supervised care, active liver disease (except non-alcoholic fatty liver disease).
• Unintentional weight loss of more than 5 kg within the prior 6 months
• Gastrointestinal malabsorption
• Unstable INR (persistently \<2 for \>14 days) or supra-therapeutic levels with concomitant bleeding or requiring hospitalisation
• Substance abuse
• Taking varenicline (smoking cessation medication)
• Chronic renal failure of stage 4 or 5

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Centre for Magnetic Resonance (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Overweight; Obesity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Rohan Wijesurendra, MB BChir MA MSc DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label randomised controlled study and patients will be aware of their treatment allocation. Potentially subjective measurements will be undertaken by observers blinded to treatment allocation; in particular, all imaging and ECG monitoring data will be anonymised prior to post-processing, and PPT score will be assessed by a research nurse blinded to treatment allocation. All study assessments will be coded and recorded blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 22, 2018
• Study Start: November 14, 2018
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)