Skip to main content
OpenTrials
Completed

NCT Number: NCT06660134

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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

Secondary outcomes

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

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

    Combine weight and height, and report the Body Mass Index (BMI) in units of kilograms per square meter (kg/m²).

  2. Quality of life assessments.

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

    The quality of life and cardiac function of the subjects were assessed using the World Health Organization Quality of Life (WHOQOL-100) questionnaire.

  3. 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

  4. Quality of life assessments

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

    Quality of life assessments were conducted within at least 12 months of follow-up using measures such as the AF6.

  5. Quality of life assessments

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

    Quality of life assessments were conducted using the AFEQT (Atrial Fibrillation Effect on Quality of Life) questionnaire.

  6. Psychological distress

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

    Psychological distress was assessed using the HADS (Hospital Anxiety and Depression Scale).

  7. Functional status

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

    Functional status was assessed using the CCS-SAF (Canadian Cardiovascular Society - Self-Assessed Functioning scale).

  8. quality of life

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

    The quality of life and cardiac function of the subjects were assessed using the New York Heart Association (NYHA) functional classification.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Hefei Second People's Hospital
  • The Second People's Hospital of Anhui Province
  • The Third Affiliated Hospital of Anhui Medical University

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.