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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Levels of inflammatory cytokine ( IL-6) in post-COVID-19 POTS and controls
Diagnostic testInflammatory 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 testInflammatory 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 testInflammatory 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
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
American Heart Association
Collaborator