NCT03713775Completed
LOSE-AF: Can Weight Loss Help Patients With Atrial Fibrillation?
Weight Loss in Elderly Patients With Atrial Fibrillation (LOSE-AF): A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 119 (actual)
- First submitted
- 15 Oct 2018
- Start date
- 14 Nov 2018
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- University of Oxford
- Diseases
- Obesity, Atrial fibrillation
- NCT number
- NCT03713775
What you commit to
- Study type: Interventional
- Participants enrolled: 119
- From 14 Nov 2018 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another research trial involving an investigational product or weight loss programme in the prior 3 months
- Current treatment with anti-obesity drugs
- 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
- Taking varenicline (smoking cessation medication)
Other illness
- Uncontrolled endocrine disorders
- Diabetes requiring insulin
- Active gout or history of recurrent gout
- Ongoing gallbladder disease
- Chronic renal failure of stage 4 or 5
Lab values
- Unstable INR (persistently \<2 for \>14 days) or supra-therapeutic levels with concomitant bleeding or requiring hospitalisation
Other
- Planned catheter ablation for AF within 8 months
- Learning difficulties or unable to understand English
- Gastrointestinal malabsorption
- Substance abuse
- Porphyria
Who the study is looking for
- Persistent AF
- Body mass index ≥27 kg/m2
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford Centre for Magnetic Resonance (OCMR) Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
Related publications
- Weight Loss in Older Patients With Persistent Atrial Fibrillation: The LOSE-AF Randomized Clinical Trial.JAMA · 2026 · PMID 42160044
This page is information, not medical advice. Discuss any trial with your doctor.