RECRUITINGINTERVENTIONAL

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

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 criteria: * 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

Treatments Being Tested

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States