The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in microbial composition of gut microbiome in study and control groups
研究概览
简要总结
Ventricular tachycardia and ventricular fibrillation (VT/VF) are the most common causes of sudden cardiac death in patients with diseased hearts. The factors contributing to these deadly arrhythmias are not well understood.
The presence of a wide variety of microbial flora in the human GI tract, particularly colon has been well recognized for a long time. There are also emerging links showing the effect of an intact gut microbiome having effects on left ventricular remodeling after myocardial infarction and hypertension. Gut microbiota has also been associated with outcomes in atrial fibrillation.
There is little available in current literature showing a relationship between gut microbiome characteristics and ventricular arrhythmia burden. The gut microbiome has particularly strong interactions with neuroendocrine and immunologic mediators and has effects on the modulation of the autonomic nervous system. These systems are also hypothesized to influence ventricular arrhythmias. The investigators propose to study the relation and interaction between gut microbiome and ventricular arrhythmogenesis.
详细描述
Specific Aims:
Aim 1: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias compared with patients with similar conventional risk factors and low burden of ventricular arrhythmias.
Aim 2: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.
Research Plan:
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center, who are individuals with underlying cardiomyopathy and prone to ventricular arrhythmias.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Inclusion criteria for all groups:
- •age >18 years-old
- •competent and willing to provide consent
- •presence of implantable cardioverter-defibrillator
- •diagnosis of cardiomyopathy
- •left ventricular ejection fraction of 35% or less as assessed by echocardiogram within 1 year prior to enrollment
- •Inclusion criteria for control group:
- •no VT/VF on device interrogation for a period of at least 3 months preceding study enrollment
- •Inclusion criteria for high ventricular arrhythmia burden group:
- •at least one episode of sustained VT/VF or VT/VF requiring ICD therapies within the preceding 3 months as assessed on device interrogation at the time of study enrollment
排除标准
- •currently pregnant or have been pregnant in the last 6 months
- •antibiotic treatment within 5 months of study enrollment (i.e. antibiotic therapy in the two months prior to the 3-month period of analysis for VT/VF)
- •chronic use of medications/supplements that can potentially affect gut microbiota (i.e. probiotics, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitors)
- •history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis, or other malabsorption disorder
结局指标
主要结局
Difference in microbial composition of gut microbiome in study and control groups
时间窗: 1 year
Microbial components identified through genetics will be compared between groups.
次要结局
- Change in microbial composition of gut microbiome after successful VT therapy(1 year)
研究者
Ramil Goel
Clinical Electrophysiologist, Malcolm Randall VAMC, Gainesville
North Florida Foundation for Research and Education