NCT06660134Completed
Strict Weight Management Based on GLP-1 RA for Ablation Outcomes in Overweight or Obese Patients with T2DM and AF
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 174 (actual)
- First submitted
- 27 Sept 2024
- Start date
- 1 Aug 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Obesity, Atrial fibrillation, Type 2 diabetes
- NCT number
- NCT06660134
What you commit to
- Study type: Interventional
- Participants enrolled: 174
- From 1 Aug 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of AF ablation treatment. History of acute coronary syndrome or percutaneous coronary intervention within 6 months prior to enrollment.
- 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.
- 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).
Other illness
- History of implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT).
- 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.
- 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.
Other
- Permanent atrial fibrillation (failed cardioversion or episode duration \>12 months).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.