Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Atrial Fibrillation
  • Overweight and Obesity
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Investigator-driven, prospective, parallel-group, double-blind, randomized controlled clinical trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04885634
Collaborators
  • Herlev and Gentofte Hospital
  • Hillerod Hospital, Denmark
  • Svendborg Hospital
  • Hospital of South West Jutland
Investigators
Study Director: Axel Brandes, MD, DMSc Odense University Hospital Study Director: Morten L Hansen, MD, PhD Herlev and Gentofte Hospital
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