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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05421208
Status
Recruiting
Apply to this trial

Conditions

  • Long COVID
  • Post-acute COVID-19 Syndrome
  • Postural Tachycardia Syndrome (POTS)
  • SARS CoV 2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Jun 1, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
    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
  • Experimental: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.
    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

Primary Outcome Measure

IL-6 levels [ Time Frame: Baseline to after 28 days of tVNS stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Cyndya Shibao, MD, MSCI
[email protected]
Cyndya A Shibao, MD, MSCI
[email protected]
6155120956
Cyndya Shibao, MD, MSCI (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Vanderbilt University Medical Center· Nashville, TN

Related Studies