Liraglutide Effect in Atrial Fibrillation
Phase 4
Active, not recruiting
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT03856632
- Lead Sponsor
- University of Miami
- Brief Summary
The goal (or purpose) of this study is to evaluate (study) a new way to stabilize (steady) the activity between the fat deposits surrounding the heart and the left atrium.
To reduce the amount of EAT, this study will use a medication called Liraglutide. This medication is known to work on fat deposits and produce weight loss. The investigator is conducting this study to find out if Liraglutide will reduce the fat deposits surrounding the participant's heart, and stabilize (and perhaps reduce or eliminate) atrial fibrillation activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male and female, age 18 or older
- Persistent AF defined as continuous AF sustained beyond 7 days (or AF with the decision to cardiovert before 7 days of enrollment or Paroxysmal AF defined as recurrent AF (≥2 episodes) that terminates spontaneously within 7 days
- BMI ≥27 kg/m2
- Patient wishes to undergo a catheter ablation procedure for the treatment of atrial fibrillation
- Receiving follow-up care at the University of Miami
Exclusion Criteria
- Inability to sign an informed consent
- Patients with longstanding persistent atrial fibrillation of more than 3 years
- Prior ablation for atrial fibrillation
- Patients not appropriate candidates for catheter ablation such as those with AF due to acute or chronic precipitating medical conditions, for example, hypothyroidism and hyperthyroidism, significant pulmonary disease, pulmonary embolism, left atrial thrombus, class IV heart failure)
- Patients with a life expectancy <1 year
- Patients with a serious medical condition (for example, recent cancer with chemotherapy or radiation therapy within 4 weeks before entering the study) who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Known contraindications to Liraglutide, such as the previous history of pancreatitis or medullary thyroid carcinoma
- Personal or family history of multiple endocrine neoplasias
- Known serious hypersensitivity reaction to Liraglutide
- Patients using, glitazones, sodium-glucose transporters 2 inhibitors (SGLT2i), other GLP-1 analogs, or DPP4 inhibitors
- Type 1 diabetes, defined by American Diabetes Association criteria, history of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes due to pancreatitis or pancreatectomy
- Poorly controlled type 2 diabetes with HbA1c > 10%
- Pregnant women
- Women who are breast-feeding or intend to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risk Factor Modification (RFM) Afib Catheter Ablation A structured risk factor modification (RFM) program currently offered to all patients who are overweight or obese undergoing an ablation procedure for atrial fibrillation.The RFM program is already offered through our Center for Atrial Fibrillation and is managed by a nurse practitioner. The RFM program will provide patient teaching and education on weight, fitness,blood pressure control, glucose control, cholesterol, sleep apnea, smoking, and alcohol. RFM plus Liraglutide RFM In addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions. Risk Factor Modification (RFM) RFM A structured risk factor modification (RFM) program currently offered to all patients who are overweight or obese undergoing an ablation procedure for atrial fibrillation.The RFM program is already offered through our Center for Atrial Fibrillation and is managed by a nurse practitioner. The RFM program will provide patient teaching and education on weight, fitness,blood pressure control, glucose control, cholesterol, sleep apnea, smoking, and alcohol. Risk Factor Modification (RFM) Anti Arrhythmics A structured risk factor modification (RFM) program currently offered to all patients who are overweight or obese undergoing an ablation procedure for atrial fibrillation.The RFM program is already offered through our Center for Atrial Fibrillation and is managed by a nurse practitioner. The RFM program will provide patient teaching and education on weight, fitness,blood pressure control, glucose control, cholesterol, sleep apnea, smoking, and alcohol. RFM plus Liraglutide Anti Arrhythmics In addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions. RFM plus Liraglutide Afib Catheter Ablation In addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions. RFM plus Liraglutide Liraglutide In addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions.
- Primary Outcome Measures
Name Time Method Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT) Baseline, 3 months (prior to ablation) As assessed via multi detector cardiac computer tomography (MD-CT)
- Secondary Outcome Measures
Name Time Method Correlation of plasminogen activator inhibitor (PAI-1), matrix metalloproteinase-2 (MMP2), Tissue inhibitor of metalloproteinase 2 (TIMP-2) During the catheter ablation procedure At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Change in C-Reactive Protein (CRP) value Baseline, 1 year post ablation Serial changes in biomarkers of inflammation
Correlation of IL-6 expression in blood from left atrium to peripheral plasma During the catheter ablation procedure At the same time point blood, will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Change in Interleukin-6 (IL-6) Baseline, 1 year post ablation Serial changes in biomarkers of inflammation
Change in size of Epicardial Adipose Tissue (EAT) thickness Baseline, 3 months (prior to ablation), 1 year post-ablation As assessed via echocardiography
Change in atrial size Baseline, 1 year post ablation As assessed via echocardiography
Correlation of CRP expression in blood from left atrium to peripheral plasma During the catheter ablation procedure At the same time point, blood will be collected directly from left atrium and peripheral vessel during the ablation procedure and compared
Change in atrial function Baseline, 1 year post ablation As assessed via echocardiography
Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP) During the catheter ablation procedure At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States