NCT06184633

DUTCH Weight Control in Atrial Fibrillation Study

DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients. Objective: Quantify the effect of an innovative weight loss management on rhythm control. Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo. Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion. Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms. Main study parameters/endpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are: * Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\* * AF despite pulmonary vein isolation * AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation * Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.

Conditions

• Atrial Fibrillation
• Obesity
• Weight Loss

Interventions

Type	Name	Description
DRUG	Semaglutide 3.2 MG/ML	Intervention arm receives semaglutide in addition to combined lifestyle intervention
DRUG	Placebo	Control arm receives placebo in addition to combined lifestyle intervention

Timeline

• Start date: 2024-07-21
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2023-12-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: Netherlands