Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-12 @ 4:13 PM
Study NCT ID:
NCT04885634
Status:
WITHDRAWN
Last Update Posted:
2023-11-03
First Post:
2021-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
Sponsor:
Axel Brandes
Organization:
Study Overview
Official Title:
Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study)
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not received funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOCRATES-AF
Brief Summary:
The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone.
Detailed Description:
The SOCRATES-AF pilot study is a prospective, parallel-group, double-blind, randomized controlled trial in patients with paroxysmal or early persistent atrial fibrillation and overweight and obesity.
The primary objective is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously (s.c.) once weekly on top of current standard care (lifestyle and risk factor management, oral anticoagulant and rate control therapy) versus current standard care alone in overweight or obese patients with symptomatic paroxysmal or early persistent AF.
To assess recurrences of atrial fibrillation all participants will receive an implantable cardiac monitor.
The primary objective is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously (s.c.) once weekly on top of current standard care (lifestyle and risk factor management, oral anticoagulant and rate control therapy) versus current standard care alone in overweight or obese patients with symptomatic paroxysmal or early persistent AF.
To assess recurrences of atrial fibrillation all participants will receive an implantable cardiac monitor.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-002017-34 | EUDRACT_NUMBER | None | View |