No phaseNot yet recruiting
Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression (DANWRAP)
- Sponsor
- Axel Brandes (Academic or other)
- Enrolment
- 480 planned
- 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)
- Ages
- adults, older adults
- Registry
- NCT07816744
From the registry
Obesity is an important risk factor for the development and progression of atrial fibrillation. Sustainable weight loss likely reduces the burden of atrial fibrillation, which has yet to be proven in adequately sized randomised trials. In a national, multicentre randomised trial we will test, whether a sustainable weight loss of more than 10% reduces atrial fibrillation progression and burden in patients with symptomatic paroxysmal or early persistent atrial fibrillation and a body mass index ≥27 kg/m2. A total of 480 patients will be randomised in a 1:1 fashion to either a comprehensive weight loss programme of behavioural support, meal replacement and/or pharmacotherapy with a glucagon-like peptide-1 receptor agonist on top of standard care aiming at more than 10% weight loss or standard care alone. Standard care will include guideline-directed anticoagulant therapy for stroke prevention, rate and/or rhythm control treatment, and management of risk factors and underlying cardiovascular conditions. Patients in the standard care group will receive information on weight management,…
Primary outcomes
- 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 monitoring