RecruitingNot ApplicableNCT05421208

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


Sponsor

Vanderbilt University Medical Center

Enrollment

60 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria14

  • 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.
  • Post-menopausal women.
  • Diabetes Mellitus Type 1 or Type 2. ,
  • Impaired Hepatic function
  • Impaired renal function test (eGFR<60 mL/min/1.73m2).
  • Ongoing substance abuse.
  • Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study.
  • History of seizures.
  • Chronic use of steroids, NSAIDs.
  • On biologics such as anti-IL6 (omalizumab) and anti-TNF-alpha drugs
  • Pregnancy or breastfeeding

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Interventions

DIAGNOSTIC_TESTLevels 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_TESTLevels 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_TESTEffect 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


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT05421208


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