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

NCT04447365 | Unknown

• 1 other identifier: 202001134
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• gut microbiome composition

  : To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.

  3 months

Study Arms (2)

control

10 patients who have had no device-monitored for ventricular tachycardia/ ventricular fibrillation the 3 months prior to recruitment will comprise a group of controls

Diagnostic Test: device interrogation

high burden of ventricular arrhythmias

20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of VT/VF requiring ICD therapies in the 3 months preceding study enrollment.

Diagnostic Test: device interrogation

Interventions

device interrogation DIAGNOSTIC_TEST

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.

control; high burden of ventricular arrhythmias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Differences in gut microbiome in patients prone to clinically significant ventricular arrhythmias compared with matched controls with no ventricular arrhythmias. Evaluate potential clinical implications of the gut microbiome as it relates to ventricular arrhythmia burden and severity. Patients with an ICD and underlying cardiomyopathy to analyze fecal samples. The patients with high burden will be re-tested after undergoing a period of treatment for their arrhythmias and demonstrating a 3 month period wherein there are no recurrent device therapies. Fecal analysis of the groups will be compared.

You may qualify if:

• 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
• no VT/VF on device interrogation for a period of at least 3 months preceding study enrollment
• 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

Sponsors & Collaborators

• North Florida Foundation for Research and Education: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool

Central Study Contacts

Ramil Goel, MD

CONTACT

716-553-3752; ramil.goel@va.gov

Cornesia Davis, MPH

CONTACT

3525486000; cornesia.davis@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: November 30, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)