Recruiting

Observational Study

Sponsor:

North Florida Foundation for Research and Education

Code:

NCT04466072

Conditions

Ventricular Tachycardia

Ventricular Fibrillation

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stool test for microbial analysis

Study Details

Brief summary:

Ventricular tachycardia and ventricular fibrillation (VT/VF) are the most common causes of sudden cardiac death in patients with diseased hearts. The factors contributing to these deadly arrhythmias are not well understood.

The presence of a wide variety of microbial flora in the human GI tract, particularly colon has been well recognized for a long time. There are also emerging links showing the effect of an intact gut microbiome having effects on left ventricular remodeling after myocardial infarction and hypertension. Gut microbiota has also been associated with outcomes in atrial fibrillation.

There is little available in current literature showing a relationship between gut microbiome characteristics and ventricular arrhythmia burden. The gut microbiome has particularly strong interactions with neuroendocrine and immunologic mediators and has effects on the modulation of the autonomic nervous system. These systems are also hypothesized to influence ventricular arrhythmias. The investigators propose to study the relation and interaction between gut microbiome and ventricular arrhythmogenesis.

Conditions

Ventricular Tachycardia

Ventricular Fibrillation

Gut Microbiome

Study ID

NCT04466072

Start date

Nov 30, 2020

Status verified date

Apr, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inclusion criteria for all groups:

  • 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 1 year 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

High Ventricular Arrhythmia burden group

Inclusion criteria for all groups:

  • 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 1 year prior to 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

Both groups will have stool sample collected for microbial analysis. This is anticipated twice for the high ventricular arrhythmia (VA) burden group. Once at the time of diagnosis of VA and later after the clinically indicated treatment for the VA.

Control group

Inclusion criteria for all groups:

  • 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 1 year 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

Both groups will have stool sample collected for microbial analysis. This is anticipated only once for the control group.

Interventions

Stool test for microbial analysis

Fecal samples will be analyzed by shotgun metagenomics and sample from the high ventricular arrhythmia burden will be compared with those from comparable control patients with low ventricular arrhythmia burden.

Primary outcome measure

  • Difference in microbial composition of gut microbiome in study and control groups [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ramil Goel, MD

7165533752ramilgoel@hotmail.com

Locations

Malcolm Randall VA medical center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Ramil Goel

716-553-3752ramilgoel@hotmail.com

More Information

Sponsor

North Florida Foundation for Research and Education

Last update posted

Apr 18, 2022

Last verified

Apr, 2022

Keywords

  • Ventricular arrhythmias
  • microbiome

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 2022-04-18.