An observational study in 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, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by North Florida Foundation for Research and Education · Observational
This study will enroll 30 subjects recruited from the electrophysiology device clinic at the VA medical center. All patients will have a pre-existing implantable cardioverter defibrillator and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment. 10 patients who have had no device-monitored ventricular fibrillation/ ventricular tachycardia for the 3 months prior to recruitment will comprise a group of controls. 20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of ventricular tachycardia/ ventricular fibrillation requiring implantable cardioverter-defibrillator therapies in the 3 months preceding study enrollment. This information will be obtained from device interrogation at the time of recruitment. Patients will provide a fecal sample for analysis at the time of enrollment.
The investigators will recruit patient from the VA pacemaker/ implantable cardioverter defibrillator clinic. Patients with ICDs will be identified before scheduled clinical visit. Patients whose ICDs on remote monitoring show evidence of VT/VF and who are being admitted to the VA medical center for expedited inpatient work up and treatment will also be offered enrollment in the study. Patients will be approached and educated about the study rationale and their involvement. Patients will be consented for participation in the study after their approval. Patients will be educated about donating fecal samples. Patients will be given fecal sampling kits to collect and subsequently mail in those samples to the University of Florida physiology laboratory where there will be processed in a HIPAA compliant way. These samples will be subjected to laboratory analysis which will be outsourced. Fecal samples will be analyzed by shotgun metagenomics to characterize the taxonomy of the gut flora and compare the taxonomic and physiologic differences between the groups.
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.
Differences in gut microbiome in patients prone to clinically significant ventricular arrhythmias compared with matched controls with no ventricular arrhythmias. Evaluate potential clinical implications of the gut microbiome as it relates to ventricular arrhythmia burden and severity. Patients with an ICD and underlying cardiomyopathy to analyze fecal samples. The patients with high burden will be re-tested after undergoing a period of treatment for their arrhythmias and demonstrating a 3 month period wherein there are no recurrent device therapies. Fecal analysis of the groups will be compared.
Inclusion Criteria:
age >18 years-old
Inclusion criteria for control group:
Inclusion criteria for high ventricular arrhythmia burden group:
Exclusion Criteria:
currently pregnant or have been pregnant in the last 6 months
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.
10 patients who have had no device-monitored for ventricular tachycardia/ ventricular fibrillation the 3 months prior to recruitment will comprise a group of controls
Diagnostic Test: device interrogation
20 patients will comprise a group of patients with high burden of ventricular arrhythmias, defined as patients with at least one sustained episode of VT/VF requiring ICD therapies in the 3 months preceding study enrollment.
Diagnostic Test: device interrogation
All patients will have a pre-existing ICD and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 3 years of the time of enrollment.
high burden arrhythmias
: To identify specific gut microbiome characteristics of patients who are prone to clinically significant or high burden of ventricular arrhythmias
Time frame: initially to 3 months
low burden arrhythmias
To identify specific gut microbiome characteristics of patients with similar conventional risk factors and low burden of ventricular arrhythmias.
Time frame: initially to 3 months
gut microbiome composition
: To examine changes that occur in the gut microbiome composition after treatment of ventricular arrhythmias.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2021. 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