Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06184633
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DUTCH Weight Control in Atrial Fibrillation Study
Sponsor:
Rijnstate Hospital
Organization:
Study Overview
Official Title:
DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUTCH-WAIST
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: