An observational study in Ventricular Tachycardia, Ventricular Fibrillation and Gut Microbiome, sponsored by North Florida Foundation for Research and Education. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by North Florida Foundation for Research and Education · Observational
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.
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.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's planned enrollment of 30 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →North Florida Foundation for Research and Education is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with underlying cardiomyopathy and having an implantable cardioverter defibrillator for protection from ventricular arrhythmias.
Inclusion Criteria:
Inclusion criteria for all groups:
Inclusion criteria for control group:
Inclusion criteria for high ventricular arrhythmia burden group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Difference in microbial composition of gut microbiome in study and control groups
Microbial components identified through genetics will be compared between groups.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
North Florida Foundation for Research and Education