Feasibility Study of GLP-1 Analogues for the Optimization of Outcomes in High BMI Patients Undergoing AbLation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Accelerated weight loss by Liraglutide on AF patients before first-time ablation and during one year follow-up [Time Frame- 13 weeks from recruitment and 52 weeks after ablation]
研究概览
简要总结
Atrial Fibrillation (AF) is the most common abnormal heart rhythm(arrhythmia) affecting about one in 40 people in England. Patients with AF often have symptoms ranging from palpitations and breathlessness, and a small number of patients may develop heart failure. The major complication of AF is stroke, and this is effectively treated with blood thinning medications (anticoagulation).
AF symptoms can lead to significant decline in quality of life and can affect patients' ability to work and exercise. There are numerous treatments targeted at maintaining normal rhythm and preventing AF recurrence. These include medications and catheter ablation.
Ablation has been shown to be more effective than medications for the long-term control of AF, but its efficacy is significantly reduced by upstream conditions such as high blood pressure, obesity, diabetes, and poor fitness levels. This results in increased complications, repeat procedures, and increased AF recurrence or patients.
Research currently available has shown that intensive risk factor control with weight loss and increased fitness can reduce AF burden and improve results from ablation. However, achieving these targets outside of a clinical trial have been challenging. Recent data has shown that a new class of drug (Liraglutide) can result in significant weight loss over a 3-month period, and pre-treatment prior to liver transplant has improved results and patient recovery.
The overall aim of this study is to determine if accelerated weight loss by Liraglutide before AF ablation is feasible to base a future trial to inform if this approach improves outcomes and can be safely adopted into routine clinical practice.
详细描述
Patients meeting the inclusion criteria waiting for atrial fibrillation (AF) ablation in Queen Elizabeth Hospital of Birmingham will be invited for the study.
The investigators aim to recruit 30 patients who meet eligibility criteria. The study will be delivered by a dedicated research fellow, supported by a team of supervising clinical researchers. The research fellow will be responsible for recruitment, study data collection, and follow up. They will also be supported by clinical research nurses.
Timeline of the study for study participants:
At 1st visit (baseline): this visit will focus on collected baseline data (listed below), education on how to administer liraglutide (weight loss medication), and use the Kardia device
The following steps will be undertaken:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study Cohort
A total of 30 patients will be included in the study group after screening of inclusion and exclusion criteria. Patients will have upstream risk factors assessed at the clinic consultation and offered risk factor optimization advice. In addition, they will received daily Liraglutide injections for 13 weeks before and 52 weeks after ablation.
干预措施: Liraglutide plus upstream risk factors modification advice and consultation (Drug)
结局指标
主要结局
Accelerated weight loss by Liraglutide on AF patients before first-time ablation and during one year follow-up [Time Frame- 13 weeks from recruitment and 52 weeks after ablation]
时间窗: 13 weeks from recruitment and 52 weeks after ablation
Weight loss: Body mass change will be measured using a single set of calibrated scales using a standardised protocol. Weight in kilograms will be measured to calculate Body Mass Index (BMI). The proportion of patients achieving \>10% weight loss, 5-9% and \< 5% weight loss will be calculated.
Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 13 weeks before and 52 weeks after ablation]
时间窗: 13 weeks before and 52 weeks after ablation
Adherence to medication: will be measured by the proportion of patients who tolerate total cumulative dose of 657 mg and more of Liraglutide at the end of follow up period (minimal maintenance dose of 1.8mg over 365 days).
Number of participants recruited over recruitment period [Time Frame-39 weeks]
时间窗: 39 weeks
The internal audit data identified, over a 2-year period, 112 patients for first time ablation with a BMI above 30. There are no competing studies, and the investigators do not expect a recruitment period of more than 39 weeks.
次要结局
- Changes in electro-anatomic mapping data in right atrium [Time Frame -at baseline and 13 weeks](Baseline and 13 weeks)
- AF burden after first-time AF ablation during one year follow-up [Time Frame-52 weeks](52 weeks)
- Changes in Epicardial Fat Volume as measured on heart MRI(CMR) [Time Frame- at baseline and 13 weeks](Baseline and 13 weeks)
- Changes in AF biomarkers [Time Frame- at baseline and 13 weeks](Baseline and 13 weeks)
- Changes in patient reported outcome measures (AFEQT- AF Effect on QualiTy of life) [Time Frame- at baseline, 13 weeks from baseline and 52 weeks after ablation](Baseline, 13 weeks from baseline and 52 weeks after ablation)
- Recurrence of AF after first-time AF ablation during one year follow-up [Time Frame- 52 weeks](52 weeks)
- Adherence to Kardia Recording Requirements [Time Frame- 39 weeks](39 weeks)
- Changes in Left Atrial Fibrosis in percentage [Time Frame- at baseline and 13 weeks](Baseline and 13 weeks)
研究者
Manish Kalla
Consultant Cardiologist and Electrophysiologist
University Hospital Birmingham