Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study)
Overview
- Phase
- Phase 3
- Intervention
- Semaglutide Injectable Product
- Conditions
- Atrial Fibrillation
- Sponsor
- Axel Brandes
- Primary Endpoint
- Number of Participants to Complete Recruitment
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Axel Brandes
Professor
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent before any study-related activity
- •≥ 18 years of age at the time of signing informed consent
- •Body mass index (BMI) ≥ 30 kg/m2
- •Body mass index (BMI) ≥ 27 kg/m2 and at least 1 concomitant cardiometabolic risk factor (hypertension, dyslipidemia, or obstructive sleep apnea)
- •Symptomatic paroxysmal or early persistent atrial fibrillation (Paroxysmal AF: Self- terminating, in most cases within 48 hours up to 7 days. AF episodes that are cardioverted within 7 days with a documented 12 lead ECG showing sinus rhythm within the last 12 months; early persistent AF: AF episodes lasting longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more. Early persistent AF in this trial is defined as persistent AF with first-time electrical cardioversion (ECV) or a maximum of 1 previous ECVs.)
Exclusion Criteria
- •General exclusion criteria
- •Age ≥75 years
- •History of type 1 or 2 diabetes (history of gestational diabetes is allowed)
- •Known or suspected hypersensitivity to study medication or related products
- •Treatment with GLP-1 receptor agonists within the last 3 months before randomisation
- •Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors
- •Alcohol/drug abuse
- •Pregnant or breastfeeding women
- •Fertile women not using chemical (tablet/pill, depot injection of progesterone, sub- dermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- •Active malignancy, unless in complete remission for ≥5 years
Arms & Interventions
Intervention group
Semaglutide 2.4 mg subcutaneously once weekly in addition to standard AF care with lifestyle and risk factor management focusing on cardiovascular risk reduction
Intervention: Semaglutide Injectable Product
Control group
Placebo treatment with volume-matched placebo s.c. once weekly in addition to standard AF care with lifestyle and risk factor management focusing on cardiovascular risk reduction
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants to Complete Recruitment
Time Frame: Up to 68 weeks, until end of treatment
Recruit 100 patients at an average recruitment rate of 2 patients per centre per month
Number of Participants to Complete Follow-up
Time Frame: Up to 75 weeks, until final follow-up
Achieve complete follow-up on 90% or more of patients
Total Resource Requirement
Time Frame: Up to 75 weeks, until final follow-up
Determine the resource requirements, i.e. primarily time spent per included patient, to achieve the recruitment and follow-up goals
Secondary Outcomes
- Efficacy of Semaglutide in Reducing AF Recurrences in Obese AF Patients(Up to 75 weeks, until final follow-up)
- Incidence of adverse effects of Semaglutide in overweight and obese AF patients(Up to 75 weeks, until final follow-up)