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

NCT05421208 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-20

No results posted yet for this study

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

Conditions

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

Interventions

DIAGNOSTIC_TEST

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

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

DIAGNOSTIC_TEST

Levels of inflammatory cytokine ( IL-6) in controls

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

DIAGNOSTIC_TEST

Effect on inflammation after chronic PNS stimulation

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

Sponsors & Collaborators

Principal Investigators

  • Cyndya Shibao, M.D · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421208 on ClinicalTrials.gov