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Clinical Trials/NCT07389941
NCT07389941Not yet recruitingPhase 4

Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation (SPICE-AF)

University of Luebeck0 sites240 target enrollmentStarted: October 1, 2026Last updated:
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Interventions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
240
Primary Endpoint
Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate whether pre-treatment with semaglutide is superior to standard care in improving freedom from atrial fibrillation (AF) at 12 months following catheter ablation in patients with obesity and symptomatic AF undergoing first-time ablation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18-80 years
  • •Symptomatic paroxysmal or persistent AF eligible for first-time catheter ablation
  • •Body mass index ≥30 kg/m or body mass index ≥28 kg/m plus ≥1 weight-related comorbidity
  • •No prior treatment with glucacon-like peptide-1 receptor agonists

Exclusion Criteria

  • •Current use of glucacon-like peptide-1 receptor agonists or dipeptidyl peptidase 4 inhibitors or use within the last 90 days prior to screening
  • •Current antiobesity medication use or use within the last 90 days prior to screening
  • •A self-reported change in body weight of >5 kg within 30 days before screening
  • •History of bariatric surgery
  • •History of diabetes mellitus
  • •Hospitalization for unstable angina, or transient ischemic attack <30 days prior to screening
  • •Pulmonary embolism <90 days before screening
  • •Myocardial infarction, or stroke <90 days prior to screening
  • •Uncontrolled thyroid disease: thyroid-stimulating hormone >10.0 mIU/L or <0.4 mIU/L at screening
  • •Active malignancy
  • •Acute pancreatitis <180 days before screening
  • •History or presence of chronic pancreatitis
  • •Chronic kidney disease with creatinine clearance <30 mL/min
  • •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • •Chronic inflammatory conditions requiring immunosuppression and/or on glucocorticoids
  • •Pregnancy, breast-feeding or planning pregnancy

Arms & Interventions

Catheter ablation for atrial fibrillation plus semaglutide

Experimental

Catheter ablation for atrial fibrillation plus semaglutide (up to 2.4 mg weekly)

Intervention: Semaglutide (SEMA) (Drug)

Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy

No Intervention

Catheter ablation for atrial fibrillation and no glucacon-like peptide-1 receptor therapy (standard therapy)

Outcomes

Primary Outcomes

Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia >30 sec) at 12 months post-ablation (8-week-blanking period)

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Luebeck
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roland Richard Tilz, MD

Director, Department of Rhythmology

University of Luebeck

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