NCT04447365

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

Status unknown Last updated 17 November 2021

What this trial tests

trial testing device interrogation in Gut Microbiome in 30 participants. Status unknown.

Timeline

30 November 2020

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	North Florida Foundation for Research and Education
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	30
Start date	30 November 2020
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	1 location across United States

Drugs / interventions tested

• device interrogation

Conditions studied

• Gut Microbiome — all drugs for Gut Microbiome →

Sponsor

North Florida Foundation for Research and Education

Who can join

18 and older, any sex, with Gut Microbiome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.