What side effects are associated with this type of intervention?

Common treatments for Post-COVID Syndrome, particularly those aimed at managing symptoms like chronic tachycardia, include medications such as Ivabradine. Ivabradine, which inhibits the If current in the sinoatrial node to reduce heart rate, can cause side effects such as bradycardia (slow heart rate), hypertension, atrial fibrillation, and visual disturbances like luminous phenomena (phosphenes). Other treatments for Post-COVID Syndrome may include beta-blockers, which can cause fatigue, cold extremities, and dizziness, and corticosteroids, which can lead to weight gain, osteoporosis, and increased risk of infections.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome that are similar to Ivabradine, which reduces heart rate by inhibiting the If current in the sinoatrial node. The management of Post-COVID Syndrome, including symptoms like chronic tachycardia, is still under investigation, and treatments are generally supportive and symptomatic. Clinical trials and further research are ongoing to identify effective therapies for this condition.

What other types of research exist?

Promising novel alternatives to Ivabradine for Post-COVID Syndrome patients in 2024 include: 1) Dronedarone, which has shown efficacy in maintaining sinus rhythm and has a favorable safety profile. 2) Vernakalant, which is effective in converting recent-onset atrial fibrillation and may help in managing tachycardia. 3) Beta-blockers like Bisoprolol, which have been effective in managing heart rate and symptoms of orthostatic intolerance. 4) Anti-inflammatory agents targeting unresolved inflammation, such as Colchicine, which may help in reducing chronic inflammation associated with post-COVID conditions.

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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:

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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.

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I have had surgery for heart or blood vessel problems.

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I understand the study and its potential effects on me.

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I have a history of heart disease, including heart attack, angina, or heart failure.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to after 28 days of tvns stimulation for reporting.

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

0 / 11Eligibility criteria met

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.