Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-24
Brief Title:
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEMINAL-AF
Brief Summary:
The goal of the study is to learn how a weight loss medication called semaglutide which is used to treat obesity in addition to standard AF treatment might affect AF atrial fibrillation severity and whether it changes the risk of atrial fibrillation recurring after standard AF treatments
Detailed Description:
Obesity and atrial fibrillation AF pose a significant burden on healthcare systems worldwide Obesity is an established independent risk factor for both the development of AF as well as increased disease severity and adverse outcomes According to a meta-analysis of 51 studies involving 60000 individuals every 5-unit increment in BMI confers an additional 19-29 risk of incident AF a 10 risk of post-operative AF and a 13 risk of post-ablation AF The estimated prevalence of AF in the United States is approximately 52 million and is expected to increase to 121 million by the year 2030 likely explained by mirroring the growth of the obesity epidemic While many associations have been made the underlying pathophysiological mechanisms linking obesity and AF are incompletely understood
Two large longitudinal cohort studies demonstrated that obesity contributes to disease progression to persistent or permanent forms of AF Importantly significant weight loss achieved by bariatric surgery has been associated with a reduction in the risk of new-onset AF by 29 in the prospective matched cohort Swedish Obese Study Weight loss achieved with intensive lifestyle modification has also been shown to impact AF burden However these studies have not systematically investigated the biological mechanisms underlying weight loss and AF
The novelty of the proposed study is that it will be the first to examine the impact of weight loss with semaglutide 24 mg on biological signaling and cardiac remodeling in relation to reductions in AF burden Additionally the proposed study will be the first to evaluate the effect of pharmacological weight loss on the risk of arrhythmia recurrence combined with antiarrhythmic drugs AAD andor catheter ablation CA which are the current first-line strategies for rhythm maintenance in patients with obesity That is relevant as obesity is a chronic and relapsing health condition as demonstrated in multiple large intensive lifestyle modification studies which show a significant weight loss in the short term but minimal weight reduction in the long-term follow up Pharmacotherapy has been shown to be superior to lifestyle modification to achieve larger and maintained weight loss
Therefore The investigators propose the first-ever double-blinded placebo controlled randomized clinical study to assess the efficacy and impact of an anti-obesity medication on atrial fibrillation in patients receiving contemporary therapies for atrial fibrillation
Two large longitudinal cohort studies demonstrated that obesity contributes to disease progression to persistent or permanent forms of AF Importantly significant weight loss achieved by bariatric surgery has been associated with a reduction in the risk of new-onset AF by 29 in the prospective matched cohort Swedish Obese Study Weight loss achieved with intensive lifestyle modification has also been shown to impact AF burden However these studies have not systematically investigated the biological mechanisms underlying weight loss and AF
The novelty of the proposed study is that it will be the first to examine the impact of weight loss with semaglutide 24 mg on biological signaling and cardiac remodeling in relation to reductions in AF burden Additionally the proposed study will be the first to evaluate the effect of pharmacological weight loss on the risk of arrhythmia recurrence combined with antiarrhythmic drugs AAD andor catheter ablation CA which are the current first-line strategies for rhythm maintenance in patients with obesity That is relevant as obesity is a chronic and relapsing health condition as demonstrated in multiple large intensive lifestyle modification studies which show a significant weight loss in the short term but minimal weight reduction in the long-term follow up Pharmacotherapy has been shown to be superior to lifestyle modification to achieve larger and maintained weight loss
Therefore The investigators propose the first-ever double-blinded placebo controlled randomized clinical study to assess the efficacy and impact of an anti-obesity medication on atrial fibrillation in patients receiving contemporary therapies for atrial fibrillation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None