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Clinical Trial Details

Trial ID: L3403
Source ID: NCT06660134
Associated Drug: Glucagon-Like Peptide-1 Receptor Agonists (Glp 1 Ra)
Title: Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)|Atrial Fibrillation (AF)
Interventions: DRUG: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
Outcome Measures: Primary: 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: 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)., 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., 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, Quality of life assessments were conducted within at least 12 months of follow-up using measures such as the AF6., 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., 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)., 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)., 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., at least 12 months of follow-up, beyond the initial 3-month blanking period
Sponsor/Collaborators: Sponsor: Shanghai Chest Hospital | Collaborators: The Third Affiliated Hospital of Anhui Medical University|The Second People's Hospital of Anhui Province|Hefei Second People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 174
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-08-01
Completion Date: 2024-01-10
Results First Posted:
Last Update Posted: 2024-10-28
Locations: Shanghai Chest Hospital, Shanghai, China
URL: https://clinicaltrials.gov/show/NCT06660134