Ventricular Tachycardia Clinical Trial
Official title:
The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Malcolm Randall VA medical center | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
North Florida Foundation for Research and Education |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in microbial composition of gut microbiome in study and control groups | Microbial components identified through genetics will be compared between groups. | 1 year | |
Secondary | Change in microbial composition of gut microbiome after successful VT therapy | Microbial components identified through genetics will be compared before and after VT therapy in the high VT burden group. | 1 year |
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