Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF

NCT06660134 | Completed

• 1 other identifier: SWGLP-AF
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Objective To compare, in patients with Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF) undergoing radiofrequency ablation (RFA), whether strict weight management and glycemic control based on Glucagon-like Peptide-1 (GLP-1) receptor agonist treatment reduces the recurrence rate of atrial arrhythmias and rehospitalization rates for cardiac diseases compared to conventional post-procedural management (antiarrhythmic drugs and anticoagulants) and general antidiabetic drugs (excluding GLP-1 receptor agonists). Study Design This trial randomly divides participants into two groups: The GLP-1 receptor agonist treatment-based strict weight management and glycemic control group. The conventional treatment group

Conditions

Type 2 Diabetes Mellitus (T2DM); Atrial Fibrillation (AF)

Keywords

Catheter ablation; Glucagon-like Peptide-1 receptor agonist; Atrial fibrillation; overweight; obesity

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia events lasting ≥30 seconds occurring from the end of a 3-month blanking period post-procedure up to 12 months of follow-up.

  at least 12 months of follow-up, beyond the initial 3-month blanking period

Secondary Outcomes (8)

• Changes in Body Mass Index (BMI) from baseline to 12 months.

  at least 12 months of follow-up, beyond the initial 3 month blanking period

• Quality of life assessments.

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• Complications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period.

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• Quality of life assessments

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• Quality of life assessments

  at least 12 months of follow-up, beyond the initial 3-month blanking period

Study Arms (2)

Strict Weight Reduction Intervention Group

EXPERIMENTAL

In addition to the routine use of Antiarrhythmic Drugs (AADs) and anticoagulants, the strict weight reduction intervention group also uses GLP-1 receptor agonists for glycemic control and weight loss according to guidelines. This group receives a structured weight loss program, regular nutritional advice in accordance with current guidelines, and physical training assistance over a 12 month period. The intervention plan aims for a total weight loss of 10 kilograms while using GLP-1 receptor agonists.

Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Standard Care Group

ACTIVE COMPARATOR

Receives standard glycemic control treatment for diabetes and follows the recommended anticoagulant and antiarrhythmic drug regimens post ablation.

Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)

Interventions

Glucagon-like peptide-1 receptor agonists (GLP 1 RA) DRUG

In addition to the routine use of Antiarrhythmic Drugs (AADs) and anticoagulants, the strict weight reduction intervention group also uses GLP-1 receptor agonists for glycemic control and weight loss according to guidelines. This group receives a structured weight loss program, regular nutritional advice in accordance with current guidelines, and physical training assistance over a 12-month period. The intervention plan aims for a total weight loss of 10 kilograms while using GLP-1 receptor agonists.

Standard Care Group; Strict Weight Reduction Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years. Symptomatic atrial fibrillation (AF) that has been ineffective or intolerable to at least one Class I or III antiarrhythmic drug.
• Diagnosed with Type 2 Diabetes Mellitus. Body Mass Index (BMI) greater than 25 kg/m². Ability to understand the purpose of the trial, willingness to participate, and signing of the informed consent form.

You may not qualify if:

• Permanent atrial fibrillation (failed cardioversion or episode duration \>12 months).
• Previous history of AF ablation treatment. History of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment.
• History of implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT).
• History of stroke or transient ischemic attack within 6 months prior to enrollment.
• Severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.
• History of left atrial appendage occlusion or planned for one-stop AF ablation and left atrial appendage occlusion.
• Pregnant, breastfeeding, or planning to become pregnant. Significant bleeding tendency precluding post-procedural systemic anticoagulation.
• Contraindications to oral hypoglycemic agents such as SGLT2 inhibitors or GLP-1 receptor agonists.
• Presence of left atrial thrombus identified before the procedure. Previous cardiac surgery (valve repair/replacement, coronary artery bypass grafting).
• Unable to perform physical exercise due to illness or disability. Significant hyperthyroidism or hypothyroidism. Drug abuse or chronic alcoholism. Comorbidity with other serious illnesses with an expected survival less than 12 months.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• The Third Affiliated Hospital of Anhui Medical University: collaborator
• The Second People's Hospital of Anhui Province: collaborator
• Hefei Second People's Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Atrial Fibrillation; Overweight; Obesity

Interventions

Glucagon-Like Peptide-1 Receptor Agonists

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xu Liu, Dr

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 28, 2024
• Study Start: August 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 10, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-09

Locations

CN (1)