Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥27 required; conditions: Atrial Fibrillation (AF); Obesity & Overweight
- Interventions
- Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA); Standard Care (in control arm)
- Conditions
- Atrial Fibrillation (AF); Obesity & Overweight
- Phase and size
- NA · 480 participants
- Dates
- Start 2026-10-01
Primary completion 2030-04 - Sponsor
- Axel Brandes (Other)
- Last checked
- Sep 20, 2026
01Endpoints
What the trial will measure
- Hierarchical composite outcome capturing AF progression and AF burden, inte-grating clinical events assessed by blinded adjudication and objective measures of AF burden, assessed by 14-day continuous ECG monitoringFrom 4 months to 12 months after enrollment
02Eligibility
Who can take part
Inclusion criteria: * Symptomatic paroxysmal\* or persistent\*\* AF * Sinus rhythm at inclusion (Visit 1) * BMI ≥27 kg/m2 * Age\>18 years * At least one 12-lead ECG or other single- or multiple-lead ECG device (e.g. Holter monitor-ing or ECG-providing wearables) documented episode during 6 months prior to inclusion \* Paroxysmal AF in this trial is defined as at least 2 episodes, either self-terminating or cardioverted within 7 days, during 6 months prior to in-clusion \*\*Persistent AF in this study is defined as the following: * Duration of an AF episode \>7 days and \< 6 months * Total documented AF history \< 5 years Exclusion criteria: * Atrial flutter as the primary arrhythmia. (Patients with previous or isolated episodes of atrial flutter may be included, provided that AF is the dominant arrhythmia and the primary target of clinical management) * Implanted electronic device (pacemaker/ICD/ICM) * Type 1 diabetes or Type 2 diabetes on insulin treatment * Severe heart failure (LVEF \<40%) * Inability to sign informed consent * Severe kidney disease (eGFR\<30) * History of catheter ablation for AF * Scheduled to receive catheter ablation for AF during the study period (next 1 year) * Incretin-based therapy (GLP-1 receptor agonists or DPP-IV inhibitors) within 30 days prior to randomization (visit 1) * Scheduled for bariatric surgery during the study period * Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis * Chronic or previous acute pancreatitis * Current participation in any other clinical intervention trial that may result in changes to med-ical management during the study period * Women of childbearing potential who are not on an acceptable form of contraception * Pregnant or breastfeeding women * Personal or family history of medullary thyroid carcinoma (MTC) * History of MEN2 (Multiple Endocrine Neoplasia type 2)
03Change log
Registry changes
No changes recorded since the trial was added.