Recruiting

Gut Microbiome

Sponsor:

North Florida Foundation for Research and Education

Code:

NCT04447365

Conditions

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

device interrogation

Study Details

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

Study ID

NCT04447365

Start date

Nov 30, 2020

Status verified date

Nov, 2021

Completion date

Sep 1, 2023

Anticipated

Primary completion date

Sep 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Inclusion criteria for control group:

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

Inclusion criteria for high ventricular arrhythmia burden group:

• 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

Primary outcome measure

  • high burden arrhythmias [ Time Frame: initially to 3 months ]
  • low burden arrhythmias [ Time Frame: initially to 3 months ]
  • gut microbiome composition [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ramil Goel, MD

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

Cornesia Davis, MPH

3525486000cornesia.davis@va.gov

Locations

North Florida/South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608

More Information

Sponsor

North Florida Foundation for Research and Education

Last update posted

Nov 17, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Florida Foundation for Research and Education on 2021-11-17.