Atrial Fibrillation, Overweight and Obesity
Conditions
Keywords
Atrial fibrillation, Overweight, Obesity, Semaglutide, Glucagon-like peptide-1 (GLP-1) receptor agonist, Implantable cardiac monitor
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.
Interventions
Subcutaneous injection of Semaglutide 2.4 mg once weekly
DRUGPlacebo
Subcutaneous injection of volume-matched placebo once weekly
Sponsors
Herlev and Gentofte Hospital
Hillerod Hospital, Denmark
Svendborg Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Axel Brandes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Investigator-driven, prospective, parallel-group, double-blind, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Complete Recruitment | 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 | Up to 75 weeks, until final follow-up | Achieve complete follow-up on 90% or more of patients |
| Total Resource Requirement | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Semaglutide in Reducing AF Recurrences in Obese AF Patients | Up to 75 weeks, until final follow-up | Collect preliminary information on the effect of semaglutide 2.4 mg s.c. once weekly on top of standard care on reducing AF recurrences in obese subjects with symptomatic paroxysmal or early persistent atrial fibrillation |
| Incidence of adverse effects of Semaglutide in overweight and obese AF patients | Up to 75 weeks, until final follow-up | Collect preliminary information on adverse drug effects, which may lead to discontinuation or dose reduction |
Outcome results
None listed