Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levels of inflammatory cytokine ( IL-6) in post-COVID-19 POTS and controls

    Diagnostic test

    Inflammatory and immune profile of post-COVID-19 POTS patients. Reduced PNS activity (vagal tone) in relation to persistent inflammation.

  • Levels of inflammatory cytokine ( IL-6) in controls

    Diagnostic test

    Inflammatory and immune profile of healthy controls. Controls are the subjects who recovered from COVID-19 infection with no sequelae.

  • Effect on inflammation after chronic PNS stimulation

    Diagnostic test

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with ControlsExperimental treatment 2 interventions
Group B: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.Experimental treatment 1 intervention

Trial outcomes

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

Time frame
Baseline to after 28 days of tVNS stimulation

Secondary outcomes

1

Orthostatic Symptoms Score

Standardized Orthostatic Symptoms Score COMPASS-31: Composite Autonomic Symptom Score EQ-5D: as a Quality of Life Measure in People with Dementia AD8 Dementia Scale: The AD8 was developed as a brief instrument to help discriminate between signs of normal aging and mild dementia. E-cog test: Everyday Cognition scales (ECog) , an informant-rated questionnaire designed to detect cognitive and functional decline.

Time frame
Baseline to after 28 days of tVNS stimulation

Other outcomes

Sponsors and contacts

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Vanderbilt University Medical Center

Lead sponsor

American Heart Association

Collaborator