Status:
UNKNOWN
Gut Microbiome and Ventricular Arrhythmias
Lead Sponsor:
North Florida Foundation for Research and Education
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 a...
Detailed 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 sim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04466072
Start Date
November 30 2020
End Date
December 31 2024
Last Update
April 18 2022
Active Locations (1)
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1
Malcolm Randall VA medical center
Gainesville, Florida, United States, 32608