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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
Be older than 18 years old
Must not have
History of seizures
History of stroke, or transient ischemic attack
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to after 28 days of tvns stimulation
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a device that sends mild electrical signals to the ear to help people with long-term symptoms after COVID-19. It focuses on those who have ongoing issues like a fast heartbeat and dizziness. The device aims to reduce inflammation and improve these symptoms by stimulating a nerve that helps control these functions.
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.
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.
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
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had seizures in the past.
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I have had a stroke or a transient ischemic attack.
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I have diabetes (Type 1 or Type 2).
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I am currently taking medications like omalizumab or anti-TNF-alpha drugs.
Select...
I have had surgery for heart or blood vessel problems.
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I understand the study and its potential effects on me.
Select...
I have a history of heart disease, including heart attack, angina, or heart failure.
Select...
I regularly use steroids or NSAIDs.
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I am a woman who has gone through menopause.
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My liver isn't working properly.
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My kidney function is reduced (eGFR<60).
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
IL-6 levels
Secondary study objectives
Orthostatic Symptoms Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-COVID Syndrome, particularly those addressing chronic tachycardia and orthostatic intolerance, often focus on regulating heart rate and improving autonomic function. Ivabradine, for example, works by inhibiting the If current in the sinoatrial node, effectively reducing heart rate without affecting blood pressure.
This is crucial for Post-COVID Syndrome patients who experience persistent tachycardia, as it helps manage heart rate and reduce symptoms like fatigue and dizziness. Other treatments may include beta-blockers, which also reduce heart rate and improve symptoms of orthostatic intolerance by blocking the effects of adrenaline on the heart.
These mechanisms are important because they directly address the dysregulated autonomic responses seen in many Post-COVID Syndrome patients, thereby improving their quality of life.
Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.
Pulmonary vasodilators: beyond the bounds of pulmonary arterial hypertension therapy in COVID-19.
Find a Location
Who is running the clinical trial?
American Heart AssociationOTHER
345 Previous Clinical Trials
4,971,365 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
198 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
939,566 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
870 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Cyndya Shibao, M.DPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
120 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
120 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
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: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.
- Group 2: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
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.
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