Weight loss program for older patients with atrial fibrillation
Weight Loss in Elderly Patients With Atrial Fibrillation (LOSE-AF): A Randomised Controlled Trial
This study is testing if a weight loss program with meal replacements and support can help older overweight patients with atrial fibrillation feel better and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT03713775 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a weight loss program, including meal replacement and behavioral support, can reduce the recurrence of atrial fibrillation (AF) and improve related symptoms in older overweight or obese patients. Atrial fibrillation is a common heart condition that significantly impacts health and quality of life, particularly in the elderly. The study aims to provide a new approach to managing AF by addressing obesity, which is a major modifiable risk factor. Participants will be compared to a control group receiving usual care to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are older adults with persistent atrial fibrillation and a body mass index of 27 kg/m2 or higher.
Not a fit: Patients with planned catheter ablation for AF, significant underlying medical conditions, or those unable to participate in the program due to language or cognitive barriers may not benefit.
Why it matters
Potential benefit: If successful, this program could provide a cost-effective strategy for managing atrial fibrillation in older patients by reducing AF recurrences and improving overall health.
How similar studies have performed: Preliminary data from other studies suggest that weight loss programs may effectively reduce AF burden, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent AF * Body mass index ≥27 kg/m2 Exclusion Criteria: * 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 * Porphyria
Where this trial is running
Oxford, Oxfordshire
- Oxford Centre for Magnetic Resonance (OCMR) — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Barbara Casadei, MD DPhil — University of Oxford
- Study coordinator: Rohan S Wijesurendra, MBBChirDPhil
- Email: rohan.wijesurendra@cardiov.ox.ac.uk
- Phone: +441865743532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.