An interventional study of Structured weight loss program including behavioral support and optional meal re-placement or pharmacotherapy with Glucagon-like peptide-1 receptor agonists (GLP1-RA) and Standard Care (in control arm) in Atrial Fibrillation (AF) and Obesity & Overweight, sponsored by Axel Brandes. Not yet recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Axel Brandes · Not applicable, Interventional, and Treatment
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Among 176 studies in Atrial Fibrillation with a site in Denmark — 32 open to participants now, 49 under way, 3 of them phase 3. Atrial Fibrillation · Denmark.
Among the 176 studies in Atrial Fibrillation with a site in Denmark, this one is the 56th largest by planned enrollment of the 140 interventional ones that give a count, is one of 9 that started in 2026, is one of 73 with no phase, reaches primary completion later than 46 of the 48 other live ones, and was the 175th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →32 of the 176 studies in Atrial Fibrillation with a site in Denmark are open now. Recruiting first, the newest first:
University College Copenhagen · Sites in Denmark
Ages 18+
Abbott Medical Devices · Sites in Denmark, Belgium, Czechia and 7 more countries
Ages 18+
Acesion Pharma · Sites in Denmark, Bulgaria, Germany and 5 more countries
Ages 18+
Herlev and Gentofte Hospital · Sites in Denmark
University of L'Aquila · Sites in Denmark, Croatia, Egypt and 12 more countries
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
176 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 17 · Phase 3 32 · Phase 4 19
First in 1999; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 480 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 273 across the 140 interventional studies, 391 across the 36 observational. Of the 117 that completed or were terminated, 40 (34%) have results posted.
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81 of 176 have an industry lead sponsor. The 10 most frequent:
Axel Brandes is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Axel Brandes has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
16 of the studies in Atrial Fibrillation with a site in Denmark that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07429214Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | 2026-12-30 |
| NCT07428564Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | 2026-12-30 |
| NCT05104658Center for Clinical Research and PreventionHeart Rehabilitation for All | 2026-12-31 |
| NCT03862859Nicholas CarlsonThe Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis | 2027-01 |
Add all 16 to your calendar (.ics) → With an account.
Among the 176 studies in Atrial Fibrillation with a site in Denmark, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one 12-lead 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:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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, including cardiovascular risk factor management, with visit frequency and follow-up similar to the intervention group.
Other: Standard Care (in control arm)
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
Guideline-directed cardiovascular risk factor management, including medical treatment and lifestyle counseling.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
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 enrollment
Plan to share: No — There is no plan at this stage, but a detailed plan may be shared at a later stage of the study.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2030, 42 months later.
Of 795 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 42 months is close to that.
Counting every sponsor, half of 1,050 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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