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

NCT ID: NCT04447365

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2023-09-01

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.

Detailed 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.

Conditions

Gut Microbiome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

device interrogation

Intervention Type: 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.

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.

device interrogation

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Florida Foundation for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ramil Goel, MD

Role: CONTACT

Phone: 716-553-3752

Email: ramil.goel@va.gov

Cornesia Davis, MPH

Role: CONTACT

Phone: 3525486000

Email: cornesia.davis@va.gov

Other Identifiers

202001134

Identifier Type: -

Identifier Source: org_study_id