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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
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.
Shanghai Chest Hospital
Shanghai, China
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.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Changes in Body Mass Index (BMI) from baseline to 12 months.
Combine weight and height, and report the Body Mass Index (BMI) in units of kilograms per square meter (kg/m²).
Time frame: at least 12 months of follow-up, beyond the initial 3 month blanking period
Quality of life assessments.
The quality of life and cardiac function of the subjects were assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire.
Time frame: 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.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Quality of life assessments were conducted within at least 12 months of follow-up using measures such as the AF6.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Quality of life assessments were conducted using the AFEQT (Atrial Fibrillation Effect on Quality of Life) questionnaire.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Psychological distress
Psychological distress was assessed using the HADS (Hospital Anxiety and Depression Scale).
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Functional status
Functional status was assessed using the CCS-SAF (Canadian Cardiovascular Society - Self-Assessed Functioning scale).
Time frame: at least 12 months of follow-up, beyond the initial 3 month blanking period
quality of life
The quality of life and cardiac function of the subjects were assessed using the New York Heart Association (NYHA) functional classification.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
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