RECRUITING

Gut Microbiome and Ventricular Arrhythmias

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias

Quick Facts

Study Start:2020-11-30
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04466072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion criteria for all groups:
  2. * age \>18 years-old
  3. * competent and willing to provide consent
  4. * presence of implantable cardioverter-defibrillator
  5. * diagnosis of cardiomyopathy
  6. * left ventricular ejection fraction of 35% or less as assessed by echocardiogram within 1 year prior to enrollment
  7. * Inclusion criteria for control group:
  8. * Inclusion criteria for high ventricular arrhythmia burden group:
  9. * 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
  1. * currently pregnant or have been pregnant in the last 6 months
  2. * 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)
  3. * 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)
  4. * history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis, or other malabsorption disorder

Contacts and Locations

Study Contact

Ramil Goel, MD
CONTACT
7165533752
ramilgoel@hotmail.com

Principal Investigator

Ramil Goel, MD
PRINCIPAL_INVESTIGATOR
Malcolm Randall VAMC

Study Locations (Sites)

Malcolm Randall VA medical center
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: North Florida Foundation for Research and Education

  • Ramil Goel, MD, PRINCIPAL_INVESTIGATOR, Malcolm Randall VAMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-30
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-11-30
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Ventricular arrhythmias
  • microbiome

Additional Relevant MeSH Terms

  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Gut Microbiome