Clinical trial NCT06660134: Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
Official title: Strict Weight Management and Glycemic Control Based on Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Treatment VS. Conventional Antidiabetic Drugs for Ablation Outcomes in Overweight or Obese Patients with Type 2 Diabetes and Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Atrial Fibrillation (AF)
Keywords: Catheter ablation
Glucagon-like Peptide-1 receptor agonist
Atrial fibrillation
overweight
obesity
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Anhui Medical University
name: The Second People's Hospital of Anhui Province
name: Hefei Second People's Hospital
First posted: 2024-10-28
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Any condition that does not align with the best interest of the subject. Other conditions determined by the investigator as unsuitable for inclusion in this study, such as psychiatric disorders or psychological impairments.

Primary outcomes:
measure: 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.
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Secondary outcomes:
measure: Changes in Body Mass Index (BMI) from baseline to 12 months.
timeFrame: at least 12 months of follow-up, beyond the initial 3 month blanking period
measure: Quality of life assessments.
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Complications associated with AF ablation and serious adverse events (such as rehospitalizations, cardiovascular rehospitalizations) occurring during the study period.
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Quality of life assessments
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Quality of life assessments
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Psychological distress
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
measure: Functional status
timeFrame: at least 12 months of follow-up, beyond the initial 3 month blanking period
measure: quality of life
timeFrame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
affiliation: Shanghai Chest Hospital
name: Xu Liu, Dr
role: PRINCIPAL_INVESTIGATOR
References: