Atrial Fibrillation (AF)DANWRAPNCT07816744
Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
A study testing Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA) in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by Axel Brandes at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Obesity & Overweight
- What is being tested?
- Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Prescott, PhD contact
Denmark2 sites
University Hospital Bispebjerg and Frederiksberg
Copenhagen
Eva Prescott, PhD, eva.irene.bossano.prescott@regionh.dk
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, 6700
Axel Brandes, M.D., +4579184491, Axel.Brandes@rsyd.dk
Axel Brandes, M.D.
About this study
Official title: The Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
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.
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Being tested
- 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)
- Keywords
- Atrial fibrillation, Overweight, Obesity, Glucagon-like peptide-1 receptor agonist, Atrial fibrillation burden
- Medical subject headings
- Atrial Fibrillation, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA)Other
Weight 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
Guideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling.
| Study group | Role | What they receive |
|---|---|---|
| Structured weight loss program | Active comparator | Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA), aiming for >10% weight loss on top of standard care. Receives: Other: 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 | Other | Standard care, including cardiovascular risk factor management, with visit frequency and follow-up similar to the intervention group. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Unplanned contact to a cardiology department or emergency department visit with a primary diagnosis of AF
- Unplanned hospital visit for heart failure
- 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
- 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
- Planned cardioversion (electrical or pharmacological), including pill-in-the-pocket therapy using Class Ic antiarrhythmic agents (e.g. flecainide)
Measured: From 4 months to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axel Brandes
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital, Rigshospitalet, Regionshospital Nordjylland, Viborg Regional Hospital, Aarhus University Hospital, Holbaek Sygehus
- Responsible party
- Sponsor-investigator, Axel Brandes, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Axel Brandes, M.D., Principal investigator, Esbjerg Hospital - University Hospital of Southern DenmarkEva Prescott, PhD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816744
- Sponsor's protocol ID
- S-20260028
- Acronym
- DANWRAP
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at this stage, but a detailed plan may be shared at a later stage of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
- ClinicalTrials.gov ID
- NCT07816744
- Acronym / sponsor ID
- DANWRAP / S-20260028
- Conditions
- Atrial Fibrillation (AF), Obesity & Overweight
- Keywords
- Atrial fibrillation, Overweight, Obesity, Glucagon-like peptide-1 receptor agonist, Atrial fibrillation burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Axel BrandesUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital, Rigshospitalet, Regionshospital Nordjylland, Viborg Regional Hospital, Aarhus University Hospital, Holbaek Sygehus
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured weight loss program | Active comparator | Other: Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA)Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA), aiming for >10% weight loss on top of standard care. |
| Standard care | Other | Other: Standard Care (in control arm)Standard care, including cardiovascular risk factor management, with visit frequency and follow-up similar to the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA)Weight 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 | Other | Structured weight loss program |
| Standard Care (in control arm)Guideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling. | Other | Standard care |
Primary outcome
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
Time frame: From 4 months to 12 months after enrollment
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan at this stage, but a detailed plan may be shared at a later stage of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Prescott, PhD contact
Axel Brandes, M.D. principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
Eva Prescott, PhD principal investigator
University Hospital Bispebjerg and Frederiksberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA) in people with Atrial Fibrillation (AF) and Obesity & Overweight, run by Axel Brandes at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Brandes, M.D. (+4579184491, Axel.Brandes@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 monitoring (time frame: From 4 months to 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.