Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
2 other identifiers
interventional
60
1 country
1
Brief Summary
The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (\~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
January 20, 2026
January 1, 2026
4.1 years
June 14, 2022
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IL-6 levels
Evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels
Baseline to after 28 days of tVNS stimulation
Secondary Outcomes (1)
Orthostatic Symptoms Score
Baseline to after 28 days of tVNS stimulation
Study Arms (2)
Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
EXPERIMENTALBiochemical 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
Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.
EXPERIMENTALEffects 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
Interventions
Inflammatory and immune profile of post-COVID-19 POTS patients. Reduced PNS activity (vagal tone) in relation to persistent inflammation.
Inflammatory and immune profile of healthy controls. Controls are the subjects who recovered from COVID-19 infection with no sequelae.
Inflammatory biomarkers after restoring PNS function in post-COVID-19 POTS patients, by chronic transcutaneous vagus nerve stimulation (tVNS) in post COVID-19 POTS patients
Eligibility Criteria
You may qualify if:
- Prior RT-PCR-confirmed COVID-19 infection.
- Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms.
You may not qualify if:
- Heart Disease: Myocardial Infarction, angina, heart failure
- History of stroke, or transient ischemic attack
- Undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)
- Uncontrolled hypertension defined as persistent blood pressure \>140/90.
- Post-menopausal women.
- Diabetes Mellitus Type 1 or Type 2. ,
- Impaired Hepatic function
- Impaired renal function test (eGFR\<60 mL/min/1.73m2).
- Ongoing substance abuse.
- Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study.
- History of seizures.
- Chronic use of steroids, NSAIDs.
- On biologics such as anti-IL6 (omalizumab) and anti-TNF-alpha drugs
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt University Medical Centerlead
- American Heart Associationcollaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cyndya Shibao, M.D
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The POTS patients will be randomized to chronic transcutaneous vagus nerve stimulation (tVNS) in any of the two sites on ear, and there will 50% change to be allocated to one of the sites that may have less stimulation.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 16, 2022
Study Start
June 1, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01