Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
NCT Number: NCT06499857
Acronym: SEMINAL-AF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Overweight or Obesity|Atrial Fibrillation
Interventions: DRUG: Semaglutide|DRUG: Placebo
Sponsor: University of Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-06
Locations: The University of Arizona College of Medicine- Phoenix, Phoenix, Arizona, 85004, United States|University of Chicago, Chicago, Illinois, 60637, United States

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.

Primary Outcome Measures: Time to first AF event detected by routine outpatient monitoring, Defined by length of time detected by routine outpatient monitoring (Holter, mobile telemetry, or implantable loop recorder)., Baseline to Week 68|Change from baseline in AF burden detected by routine outpatient monitoring., Defined as the percentage of time spent in atrial fibrillation as detected by routine outpatient monitoring (Holter, mobile telemetry, or implantable loop recorder)., Baseline to Week 68
Secondary Outcome Measures: Weight loss, Change in Weight (kilograms) measured., Baseline to Week 68|Change in waist circumference, Change waist circumference (cm) measured., Baseline to Week 68|Change in epicardial and/or pericardial adipose tissue volume, Decrease measured by Cardiovascular magnetic resonance, Baseline to Week 68|Change in left and right ventricular size (mass), Change in left and right ventricular size derived from time volume curves, and left and right atrial volumes (mL) measured by cardiovascular magnetic resonance, Baseline to Week 68|Change in left and right ventricular size (volume), Change in left and right ventricular size derived from time volume curves, and left and right atrial volumes (mL) measured by cardiovascular magnetic resonance, Baseline to Week 68|Change in left and right ventricular function (ejection fraction), Change in left and right ventricular function derived from time volume curves, and left and right atrial volumes (mL) measured by cardiovascular magnetic resonance, Baseline to Week 68|Change in left ventricular strain, Change in left ventricular strain derived from time volume curves, and left and right atrial volumes (mL) measured by cardiovascular magnetic resonance, Baseline to Week 68|Change in left ventricular diastolic parameters, Change in left ventricular strain diastolic parameters measured by cardiovascular magnetic resonance, Baseline to Week 68|Change in LV (left ventricular) myocardial fibrosis, Decrease in LV (%)myocardial fibrosis burden as measured by changes in native myocardial T1 times (milliseconds) measured by Cardiovascular magnetic resonance, Baseline to Week 68|Change in sympathetic activity and in circulating cytokines and adipokines, Decrease in systemic inflammation as measured by the levels of circulating cytokines and adipokines such as \[CRP(C-reactive protein), TNF(Tumor necrosis factor), IL-6 (Interleukin 6), IL-1 alpha beta IL-8, IL-10, 16-18 monocyte chemoattractant protein (MCP-1), VEGF (Vascular endothelial growth factor)\] (pg/mL) and adipokines (leptin, adiponectin, resistin, and visfatin) (pg/mL)., Baseline to Week 68|Change in Autonomic tone as determined by heart rate variability, HRV (milliseconds) will measured from baseline to Week 68 by outpatient rhythm monitoring, Baseline to Week 68|Changes from baseline through Week 68 of Atrial conduction times, Estimated by simple P wave duration (milliseconds) measured by 12-lead ECG, Baseline to Week 68|Changes in Body mass composition, Change in Body mass composition (percentage) measured by bio-impedance, Baseline to Week 68|Changes in Metabolic effects, Metabolic effects measured by CMP/HgA1C (mmol/mol and %), Baseline to Week 68|Left atrial and myocardial stress, Change measured by Serum BNP (pg/mL), which reflects left atrial and myocardial stress, Baseline to Week 68|Changes from baseline through Week 68 of novel Patient Reported Outcome Assessment., Detection of within-patient changes on impact of health on an individual's everyday life reported in a novel Patient-Reported Outcome Assessment between baseline and Week 68., Baseline to Week 68