The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.

Gut Microbiome Clinical Trial

Official title:

The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447365
• Other study ID #: 202001134
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2021
• Source: North Florida Foundation for Research and Education
• Contact: Ramil Goel, MD
• Phone: 716-553-3752
• Email: ramil.goel[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center. All patients will have a pre-existing implantable cardioverter defibrillator and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment. 10 patients who have had no device-monitored ventricular fibrillation/ ventricular tachycardia for the 3 months prior to recruitment will comprise a group of controls. 20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of ventricular tachycardia/ ventricular fibrillation requiring implantable cardioverter-defibrillator therapies in the 3 months preceding study enrollment. This information will be obtained from device interrogation at the time of recruitment. Patients will provide a fecal sample for analysis at the time of enrollment.

Description:

The investigators will recruit patient from the VA pacemaker/ implantable cardioverter defibrillator clinic. Patients with ICDs will be identified before scheduled clinical visit. Patients whose ICDs on remote monitoring show evidence of VT/VF and who are being admitted to the VA medical center for expedited inpatient work up and treatment will also be offered enrollment in the study. Patients will be approached and educated about the study rationale and their involvement. Patients will be consented for participation in the study after their approval. Patients will be educated about donating fecal samples. Patients will be given fecal sampling kits to collect and subsequently mail in those samples to the University of Florida physiology laboratory where there will be processed in a HIPAA compliant way. These samples will be subjected to laboratory analysis which will be outsourced. Fecal samples will be analyzed by shotgun metagenomics to characterize the taxonomy of the gut flora and compare the taxonomic and physiologic differences between the groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • 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 3 years 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Gut Microbiome

Intervention

Diagnostic Test:
• device interrogation
All patients will have a pre-existing ICD and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
North Florida Foundation for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high burden arrhythmias	: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias	initially to 3 months
Primary	low burden arrhythmias	To identify specific gut microbiome characteristics of patients with similar conventional risk factors and low burden of ventricular arrhythmias.	initially to 3 months
Primary	gut microbiome composition	: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.	3 months