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

NCT04447365 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-11-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • North Florida Foundation for Research and Education

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447365 on ClinicalTrials.gov