Gut Microbiome and Ventricular Arrhythmias

Status unconfirmed

Conditions studied: Ventricular Tachycardia, Ventricular Fibrillation, Gut Microbiome

In brief

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.

Key facts

Study ID

NCT04466072

Run by

North Florida Foundation for Research and Education

People needed

30

Starts

2020-11-30

Expected to finish

2024-12-31

Last updated by the study team

2022-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Malcolm Randall VA medical center — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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