Gut Microbiome and Ventricular Arrhythmias
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gut Microbiome
- Ventricular Fibrillation
- Ventricular Tachycardia
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 t...
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. Out of this cohort, we will identify 2 groups who have different ventricular arrhythmia burden despite similar conventional clinical factors. This information regarding ventricular arrhythmia burden will be obtained from device interrogation at the time of recruitment. Our proposal is study and compare the fecal microbial composition of these groups to analyze association with ventricular arrhythmia burden. Patients will provide a fecal sample for analysis at the time of enrollment. After clinically indicated treatment in the high ventricular arrhythmia group, we will retest fecal samples to assess for changes in characteristics after treatment. This will be done to study changes in the gut microbiome with ventricular arrhythmia in the same individual. After initial testing of the high burden group, they will undergo treatment aimed at decreasing their burden of arrhythmia, with some combination of anti-arrhythmic drugs, sympathetic blockade, or ventricular tachycardia ablation. After demonstrating a period of 3 months without sustained VT/VF on device interrogation, their fecal samples will be re-analyzed. If a patient continues to have VT/VF requiring intermittent device therapies despite a 6 month period of intensification of therapy, their fecal sample will be re-analyzed after that 6 month timeframe.
Tracking Information
- NCT #
- NCT04466072
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ramil Goel, MD Malcolm Randall VAMC