Gut Microbiome and Ventricular Arrhythmias

NCT04466072 | Unknown DMC

• 1 other identifier: IRB202001134
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Ventricular arrhythmias; microbiome

Outcome Measures

Primary Outcomes (1)

• Difference in microbial composition of gut microbiome in study and control groups

  Microbial components identified through genetics will be compared between groups.

  1 year

Secondary Outcomes (1)

• Change in microbial composition of gut microbiome after successful VT therapy

  1 year

Study Arms (2)

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.

Diagnostic Test: Stool test for microbial analysis

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.

Diagnostic Test: Stool test for microbial analysis

Interventions

Stool test for microbial analysis DIAGNOSTIC_TEST

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.

Control group; High Ventricular Arrhythmia burden group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with underlying cardiomyopathy and having an implantable cardioverter defibrillator for protection from ventricular arrhythmias.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Florida Foundation for Research and Education: lead

Study Sites (1)

Malcolm Randall VA medical center

Gainesville, Florida, 32608, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected and analyzed for bacterial DNA analysis to characterize nature and function of microbial flora. Host human DNA may be a contaminant

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ramil Goel, MD

  Malcolm Randall VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramil Goel, MD

CONTACT

7165533752; ramilgoel@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Electrophysiologist, Malcolm Randall VAMC, Gainesville

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: November 30, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)