Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxel Brandes
About this trial
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, but no active treatment for weight loss. Patients will be enrolled during a period of two and a half years and will be followed for one year with an equal number of study visits in both study arms. All patients will receive a 14-day continuous electrocardiographic monitoring at baseline, four, eight, and 12 months.
The study endpoints will be assessed after a 4-months blanking period from month four to 12 to allow for weight loss. The primary endpoint will be a hierarchical composite of atrial fibrillation progression, symptom burden, and treatment escalation. Secondary endpoints will be a change in weight, total atrial fibrillation burden, quality of life, and metabolic and cardiovascular biomarkers from baseline to 12 months. Safety endpoints will be adverse events related to treatment with glucagon-like peptide-1 receptor agonists and weight loss. Endpoint adjudication will be blinded.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic paroxysmal* or persistent** AF
Sinus rhythm at inclusion (Visit 1)
BMI ≥27 kg/m2
Age>18 years
Disqualifiers
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%)
Trial design
Design model
Parallel
Treatments tested in this trial
Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA)
Other interventionWeight loss period (0-16 weeks): Behavioural support (first step): Dietician-guided lifestyle vhanges through virtual meeting, frequency by patient's choice; energy intake 1500 kcal/day; \<30% carbohydrates, \>=60 g protein/day, adeqaute fiber, 2-2.5 L/day non-caloric fluids. Escalation strategy (second step): Meal replacement: available free of charge Pharmacotherapy: Semaglutide once weekly subcutaneous injection Target weight loss \>10%; aiming for a 1% weight loss per week during the weight loss period. Weight loss maintenance period (17-52 weeks): Maintenance of \>10% weigth loss Further lifestyle changes, meal replacement, or dose adjustment of weight loss medication
Standard Care (in control arm)
Other interventionGuideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Structured weight loss programActive comparator 1 intervention
Group B: Standard careOther 1 intervention
Trial outcomes
Primary outcomes
1
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
The hierarchical components of the primary outcome are: 1. Unplanned contact to a cardiology department or emergency department visit with a primary diagnosis of AF 2. Unplanned hospital visit for heart failure 3. High AF burden defined as: AF burden ≥10% (i.e., ≥33.8 hours of cumulative AF) during any of the 14-day ECG monitoring periods at 4, 8, or 12 months 4. Moderate AF burden defined as: AF burden ≥5% (i.e., ≥16.8 hours of cumulative AF) during any of the 14-day ECG monitoring periods at 4, 8, or 12 months 5. Planned cardioversion (electrical or pharmacological), including pill-in-the-pocket therapy using Class Ic antiarrhythmic agents (e.g. flecainide)
Time frame
From 4 months to 12 months after enrollmentSponsors and contacts
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Axel Brandes
Lead sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor institution
University Hospital Bispebjerg and Frederiksberg
Collaborator
Copenhagen University Hospital, Rigshospitalet
Collaborator
Regionshospital Nordjylland
Collaborator
Viborg Regional Hospital
Collaborator
Aarhus University Hospital
Collaborator
Holbaek Sygehus
Collaborator
Source ClinicalTrials.gov
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