Your session is about to expire
← Back to Search
Mechanisms of Post COVID-19 Tachycardia Syndrome
N/A
Recruiting
Led By Cyndya Shibao, M.D
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (>30 bpm) and chronic (>3 months) pre-syncopal symptoms
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to after 28 days of tvns stimulation
Awards & highlights
Study Summary
This trial is testing if a drug can help with a condition called Long COVID, which is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections.
Who is the study for?
This trial is for individuals who previously had COVID-19 and now suffer from a condition called post-COVID-19 POTS, characterized by rapid heartbeat when standing up and symptoms like dizziness lasting over 3 months. It's not for those with heart disease, on certain medications like steroids or biologics, post-menopausal women, pregnant or breastfeeding people, those with liver issues, seizure history, recent cardiovascular procedures, substance abuse problems, severe mental conditions, stroke history or impaired kidney function.Check my eligibility
What is being tested?
The study investigates the role of inflammation in long-term rapid heartbeat after COVID-19 (post-COVID-19 POTS). Researchers are measuring levels of an inflammatory marker (IL-6) and examining the effects of chronic stimulation of the parasympathetic nervous system to reduce inflammation in affected patients compared to healthy controls.See study design
What are the potential side effects?
Since this trial focuses on monitoring biological markers rather than testing new drugs or therapies directly administered to participants there may be minimal side effects related specifically to the interventions being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a fast heart rate and near-fainting for over 3 months after COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to after 28 days of tvns stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to after 28 days of tvns stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IL-6 levels
Secondary outcome measures
Orthostatic Symptoms Score
Trial Design
2Treatment groups
Experimental Treatment
Group I: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.Experimental Treatment1 Intervention
Effects of restoring PNS function in post-COVID-19 POTS patients with chronic transcutaneous vagus nerve stimulation (tVNS) on inflammation, orthostatic tachycardia and OI symptoms.The subjects with POTS will be randomized, where TENS 7000 device will be placed to active and sham location.Autonomic symptoms assessment questionnaire (COMPASS-31),32 quality of life EQ-5D and neuropsychological tests
Group II: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with ControlsExperimental Treatment2 Interventions
Biochemical endpoints: Measurement of Inflammatory markers (especially IL-6) in both Post- COVID-19 POTS patients and compare it with controls.
Controls are the participants who recovered from COVID 19 infection with no sequelae
Find a Location
Who is running the clinical trial?
American Heart AssociationOTHER
324 Previous Clinical Trials
4,933,718 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,132 Total Patients Enrolled
Cyndya Shibao, M.DPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously tested positive for COVID-19 using a specific test called RT-PCR.I have had seizures in the past.I have diabetes (Type 1 or Type 2).I have had a fast heart rate and near-fainting for over 3 months after COVID-19.I am currently taking medications like omalizumab or anti-TNF-alpha drugs.I have had a stroke or a transient ischemic attack.I have had a fast heart rate and near-fainting for over 3 months after COVID-19.I have had surgery for heart or blood vessel problems.I understand the study and its potential effects on me.I have a history of heart disease, including heart attack, angina, or heart failure.I regularly use steroids or NSAIDs.I am a woman who has gone through menopause.My liver isn't working properly.You are currently abusing drugs or alcohol.My kidney function is reduced (eGFR<60).Your blood pressure is consistently higher than 140/90.You have had a confirmed COVID-19 infection detected by a specific test called RT-PCR.
Research Study Groups:
This trial has the following groups:- Group 1: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
- Group 2: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings for volunteers to join this experiment?
"According to the clinicaltrials.gov listing, this trial is currently recruiting patients. It was first listed on June 1st 2022 and last updated two weeks later on June 14th of that year."
Answered by AI
To what extent is the clinical trial participant pool being expanded?
"Affirmative. Clinicaltrials.gov data confirms this particular medical trial is actively looking for volunteers, with the original posting date being June 1st 2022 and last edited on 14th of that same month. The clinical trial requires 60 participants from just one site to participate."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger