Ventricular TachycardiaNCT04466072
Gut Microbiome and Ventricular Arrhythmias
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by North Florida Foundation for Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation, Gut Microbiome
- What is being tested?
- Stool test for microbial analysis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with underlying cardiomyopathy and having an implantable cardioverter defibrillator for protection from ventricular arrhythmias.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Malcolm Randall VA medical center
Gainesville, Florida, 32608
Ramil Goel, 716-553-3752, ramilgoel@hotmail.com
About this study
Official title: The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias
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.
Read the detailed description
Specific Aims:
Aim 1: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias compared with patients with similar conventional risk factors and low burden of ventricular arrhythmias.
Aim 2: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.
Research Plan:
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center, who are individuals with underlying cardiomyopathy and prone to ventricular arrhythmias.
Out of this cohort, the investigators will identify 2 groups who have different ventricular arrhythmia burden despite similar conventional clinical factors.
This information regarding ventricular arrhythmia burden will be obtained from device interrogation at the time of recruitment. Our proposal is study and compare the fecal microbial composition of these groups to analyze association with ventricular arrhythmia burden. Patients will provide a fecal sample for analysis at the time of enrollment.
After clinically indicated treatment in the high ventricular arrhythmia group, the investigators will retest fecal samples to assess for changes in characteristics after treatment. This will be done to study changes in the gut microbiome with ventricular arrhythmia in the same individual.
After initial testing of the high burden group, they will undergo treatment aimed at decreasing their burden of arrhythmia, with some combination of anti-arrhythmic drugs, sympathetic blockade, or ventricular tachycardia ablation. After demonstrating a period of 3 months without sustained VT/VF on device interrogation, their fecal samples will be re-analyzed. If a patient continues to have VT/VF requiring intermittent device therapies despite a 6 month period of intensification of therapy, their fecal sample will be re-analyzed after that 6 month timeframe.
- Being tested
- Stool test for microbial analysis
- Keywords
- Ventricular arrhythmias, microbiome
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool test for microbial analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Stool test for microbial analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in microbial composition of gut microbiome in study and control groups
Microbial components identified through genetics will be compared between groups.
Measured: 1 year
Secondary outcomes (1)
Change in microbial composition of gut microbiome after successful VT therapy
Microbial components identified through genetics will be compared before and after VT therapy in the high VT burden group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start30 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramil Goel, North Florida Foundation for Research and Education
- Investigators
- Ramil Goel, MD, Principal investigator, Malcolm Randall VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466072
- Sponsor's protocol ID
- IRB202001134
- Status last verified
- Apr 2022
- First submitted
- 7 Jul 2020
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT04466072
- Acronym / sponsor ID
- IRB202001134
- Keywords
- Ventricular arrhythmias, microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims:
Aim 1: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias compared with patients with similar conventional risk factors and low burden of ventricular arrhythmias.
Aim 2: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.
Research Plan:
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center, who are individuals with underlying cardiomyopathy and prone to ventricular arrhythmias.
Out of this cohort, the investigators will identify 2 groups who have different ventricular arrhythmia burden despite similar conventional clinical factors.
This information regarding ventricular arrhythmia burden will be obtained from device interrogation at the time of recruitment. Our proposal is study and compare the fecal microbial composition of these groups to analyze association with ventricular arrhythmia burden. Patients will provide a fecal sample for analysis at the time of enrollment.
After clinically indicated treatment in the high ventricular arrhythmia group, the investigators will retest fecal samples to assess for changes in characteristics after treatment. This will be done to study changes in the gut microbiome with ventricular arrhythmia in the same individual.
After initial testing of the high burden group, they will undergo treatment aimed at decreasing their burden of arrhythmia, with some combination of anti-arrhythmic drugs, sympathetic blockade, or ventricular tachycardia ablation. After demonstrating a period of 3 months without sustained VT/VF on device interrogation, their fecal samples will be re-analyzed. If a patient continues to have VT/VF requiring intermittent device therapies despite a 6 month period of intensification of therapy, their fecal sample will be re-analyzed after that 6 month timeframe.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Ventricular Arrhythmia burden group | – | Diagnostic Test: Stool test for microbial analysisInclusion 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 | – | Diagnostic Test: Stool test for microbial analysisInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with underlying cardiomyopathy and having an implantable cardioverter defibrillator for protection from ventricular arrhythmias.
Key inclusion criteria (8 listed)
- Inclusion criteria for high ventricular arrhythmia burden group:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool test for microbial analysisFecal 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. | Diagnostic test | Control group, High Ventricular Arrhythmia burden group |
Primary outcome
Difference in microbial composition of gut microbiome in study and control groups
Time frame: 1 year
Microbial components identified through genetics will be compared between groups.
1 secondary outcome
Change in microbial composition of gut microbiome after successful VT therapy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramil Goel, MD principal investigator
Malcolm Randall VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by North Florida Foundation for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramil Goel, MD (7165533752, ramilgoel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in microbial composition of gut microbiome in study and control groups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.