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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Meena Vinayagam, M.D.
meenakshi.golchha@vumc.org
615-322-3447
Backup
Cyndya Shibao, MD
cyndya.shibao@vumc.org
615-421-2998
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 60
Treatments
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
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov