DUTCH Weight Control in Atrial Fibrillation Study

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

Quantify the effect of an innovative weight loss management on rhythm control.

It had two arms (groups): Intervention (active comparator) and Placebo (placebo comparator).

Semaglutide injections + combined lifestyle intervention.

Placebo Semaglutide injections + combined lifestyle intervention.

The registry classes the interventions as drug.

More on the Plan

Objective: Quantify the effect of an innovative weight loss management on rhythm control.

Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.

Who Took Part

Enrollment: 280 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -. Age ≥ 18. Obesity, as defined as:. BMI ≥ 30 kg/m2, or. BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease).

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: permanent af; secondary af, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery; current or previous treatment with amiodaron.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-07-21 with completion listed for 2027-04-10.

It ran at 20 sites in Netherlands (20).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit, Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit, Number of scheduled electrical cardioversions, Number of unscheduled electrical cardioversions, Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs) and Total number of unscheduled cardioverions.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 280 people with fat loss, obesity & body recomposition.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.