NCT04447365

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: North Florida Foundation for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-30
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-06-25
• Last updated: 2021-11-17

Locations

1 site across 1 country: United States