Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF)
概览
- 阶段
- 4 期
- 干预措施
- Afib Catheter Ablation
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- University of Miami
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
- 状态
- 进行中（未招募）
- 最后更新
- 昨天
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Risk Factor Modification (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.
干预措施: Afib Catheter Ablation
RFM plus 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.
干预措施: RFM
Risk Factor Modification (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.
干预措施: RFM
Risk Factor Modification (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.
干预措施: Anti Arrhythmics
RFM plus 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.
干预措施: Anti Arrhythmics
RFM plus 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.
干预措施: Afib Catheter Ablation
RFM plus 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.
干预措施: Liraglutide
结局指标
主要结局
Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
时间窗: Baseline, 3 months (prior to ablation)
As assessed via multi detector cardiac computer tomography (MD-CT)
次要结局
- Correlation of plasminogen activator inhibitor (PAI-1), matrix metalloproteinase-2 (MMP2), Tissue inhibitor of metalloproteinase 2 (TIMP-2)(During the catheter ablation procedure)
- Change in C-Reactive Protein (CRP) value(Baseline, 1 year post ablation)
- Correlation of IL-6 expression in blood from left atrium to peripheral plasma(During the catheter ablation procedure)
- Change in Interleukin-6 (IL-6)(Baseline, 1 year post ablation)
- Change in size of Epicardial Adipose Tissue (EAT) thickness(Baseline, 3 months (prior to ablation), 1 year post-ablation)
- Change in atrial size(Baseline, 1 year post ablation)
- Correlation of CRP expression in blood from left atrium to peripheral plasma(During the catheter ablation procedure)
- Change in atrial function(Baseline, 1 year post ablation)
- Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP)(During the catheter ablation procedure)