DUTCH Weight Control in Atrial Fibrillation Study — DUTCH-WAIST  

Obesity Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Body Weight
• Obesity
• Weight Loss

• NCT number: NCT06184633
• Study type: Interventional
• Source: Rijnstate Hospital
• Contact: Leonard Voorhout, MSc
• Phone: +31650818296
• Email: lvoorhout@rijnstate.nl
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Completion date: May 1, 2027