Study Stopped
Not received funding.
Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
SOCRATES-AF
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 3, 2023
November 1, 2023
1.3 years
May 10, 2021
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants to Complete Recruitment
Recruit 100 patients at an average recruitment rate of 2 patients per centre per month
Up to 68 weeks, until end of treatment
Number of Participants to Complete Follow-up
Achieve complete follow-up on 90% or more of patients
Up to 75 weeks, until final follow-up
Total Resource Requirement
Determine the resource requirements, i.e. primarily time spent per included patient, to achieve the recruitment and follow-up goals
Up to 75 weeks, until final follow-up
Secondary Outcomes (2)
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
Study Arms (2)
Intervention group
ACTIVE COMPARATORSemaglutide 2.4 mg subcutaneously once weekly in addition to standard AF care with lifestyle and risk factor management focusing on cardiovascular risk reduction
Control group
PLACEBO COMPARATORPlacebo 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
Interventions
Subcutaneous injection of Semaglutide 2.4 mg once weekly
Subcutaneous injection of volume-matched placebo once weekly
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- Inflammatory bowel diseases
- Acute or chronic pancreatitis
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
- Current history of treatment with medications that may cause significant weight gain, within the last 3 months before screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Axel Brandeslead
- Herlev and Gentofte Hospitalcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Svendborg Hospitalcollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Axel Brandes, MD, DMSc
Odense University Hospital
- STUDY DIRECTOR
Morten L Hansen, MD, PhD
Herlev and Gentofte Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 13, 2021
Study Start
October 1, 2022
Primary Completion
January 1, 2024
Study Completion
November 1, 2024
Last Updated
November 3, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share