DUTCH weight control in atrial fibrillation study (DUTCH-WAIST) : Design and rationale of a randomised controlled trial
- Design
- Randomized trial · None outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationINDIRECT: entry requires obesity or overweight with a weight-related comorbidity, plus persistent atrial fibrillation.
- Could weight loss explain it?
- Not applicableDesign paper with no outcome yet. The trial is framed as testing weight loss itself as the means of improving rhythm control.
- Study tier
- Not ratedNOT_RATED: a design and rationale paper that reports no outcome data.
- Assessment
- Version 5 · Two independent AI reviews agreed · Nov 7, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
This paper describes the design of a Dutch double-blind trial that will give semaglutide 2.4 mg weekly or placebo, on top of a lifestyle programme, to adults with overweight or obesity and newly detected persistent atrial fibrillation. The main outcomes are heart-rhythm status and a composite of persistent atrial fibrillation, ablation, arrhythmic death or serious drug side effects at one year. No results are reported yet.
What the study reported
- Drugs
- Semaglutide
- Dose
- 2.4 mg once weekly
- Route
- subcutaneous
- Comparator
- placebo, alongside combined lifestyle intervention and standard AF care in both groups
- Treatment duration
- one-year period
- Primary outcome
- co-primary: hierarchical rhythm status at one year; composite of persistent AF, AF ablation, arrhythmic death or serious adverse event from anti-arrhythmic drugs within 1 year (planned, no results)
- Effect
- not reported in abstract
- 95% confidence interval
- Not extracted
- Follow-up
- one year
- Adverse events
- not reported in abstract
- Limitations
- Design and rationale paper with no results yet; the abstract gives no planned sample size.
Who was studied
- Bmi min
- > 30 kg/m2, or BMI > 27 kg/m2 with a weight-related comorbidity
- Obesity status
- required (BMI > 30 kg/m2, or BMI > 27 kg/m2 with a weight-related comorbidity)
- Diabetes status
- not reported in abstract
- Cvd status
- first detected persistent atrial fibrillation required
- Ckd status
- not reported in abstract
- Baseline condition
- first detected persistent atrial fibrillation scheduled for electrical cardioversion, with overweight or obesity
- Inclusion exclusion
- adults with BMI > 30 kg/m2 (or > 27 kg/m2 with comorbidity) and first detected (< 6 months) persistent AF scheduled for cardioversion
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- not extracted
- Randomization
- yes
- Blinding
- double-blind
- Comparator
- placebo, alongside combined lifestyle intervention and standard AF care in both groups
- Follow up duration
- one year
- Outcome type
- none
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- INDIRECT
- Statistical precision
- no results reported (design paper)
- Risk of bias
- not assessed
- Peer review status
- yes
Funding and conflicts
- Funding
- Hartstichting
- Industry funded
- No
- Manufacturer
- not stated in source
- Sponsor role
- not reported in abstract
- Author conflicts
- One co-author (M. Hemels) is a Deputy Editor of the Netherlands Heart Journal and received lecture payments from Novo Nordisk; the other authors declare no competing interests.
- Independent replication
- unknown
- Notes
- Authors declare relationships with the drug's manufacturer: Novo Nordisk (lecture payments to one co-author)
Funding is shown on every study and never used to score it.
The source, as retrieved
Abstract
[BACKGROUND] Obesity is a well-established and highly prevalent risk factor for atrial fibrillation (AF) and its progression by promoting structural and electrical atrial remodelling, leading to AF recurrence and persistence. Weight loss is expected to reverse atrial remodelling and improve rhythm control. Optimal strategies for weight management are, however, under-explored. [OBJECTIVE] To quantify the effect of clinically meaningful weight loss on rhythm control in overweight patients with first detected persistent AF. [DESIGN] A multicentre, double-blind, randomised, placebo-controlled trial evaluating semaglutide 2.4 mg once weekly versus placebo, in addition to combined lifestyle intervention (CLI), during a one-year period. [PARTICIPANTS] Adults with a BMI > 30 kg/m2, or BMI > 27 kg/m2 with a weight-related comorbidity, and first detected (< 6 months) persistent AF scheduled for electrical cardioversion. [INTERVENTION] Weekly subcutaneous injections of semaglutide 2.4 mg or placebo, alongside CLI and standard AF care in both groups. [OUTCOMES] The co-primary outcome is (i) a hierarchical assessment of rhythm status at one year, ranking patients by severity from arrhythmic death to sinus rhythm without any additional rhythm control support. (ii) the composite of either persistent atrial fibrillation on ECG, catheter ablation for AF, arrhythmic death, or any serious adverse event due to anti-arrhythmic drugs occurring within 1 year. [CONCLUSION] This study investigates whether treatment of overweight with semaglutide, as an adjunct to lifestyle intervention, enhances rhythm control in AF patients with first detected persistent AF and overweight, offering a potential new approach to reducing AF burden and cardiovascular risk in this population.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 20, 2026 | 42734721 first ingestion |
| pubmed | Sep 27, 2026 | 42734721 duplicate matched on doi |
| owner-review | Nov 6, 2026 | reviewed_by set to Carrie Schluter (2026-11-05) on the owner's own confirmation. The assessment is unchanged and still the auto-classifier's, so its extracted values stay withheld under the 2026-10-18 decision. |
| reextract | Nov 6, 2026 | manufacturer: 'Novo Nordisk' -> None; dose: '2.4 mg once weekly' -> '2.4 mg'. Q-043: manufacturer and drug_details.dose re-extracted by auto-classifier-v1.2. manufacturer no longer reads companies named only in the authors' conflicts statement (IN-062) and refuses a multi-company roster; dose is tied to the GLP-1 agent by name, never reads a concentration, and records a multi-dose design whole. Every other value is carried forward unchanged. Owner decision IN-064 option 1, 2026-11-06. |
| reextract | Nov 6, 2026 | drug_details.dose: '2.4 mg' -> '2.4 mg once weekly'. Q-043: manufacturer, drug_details.dose and the funding fields re-extracted by auto-classifier-v1.2. manufacturer no longer reads companies named only in the authors' conflicts statement (IN-062) and refuses a multi-company roster; dose is tied to the GLP-1 agent by name, never reads a concentration, records a multi-dose design whole and keeps a frequency written beside the amount; industry_funded, sponsor_role and funding_source read the conflicts statement's own sponsor sentences, a supplier counting as partial. Every other value is carried forward unchanged, evidence_level included. Owner decisions IN-064, 2026-11-06. |