Understanding and treating post-COVID-19 tachycardia syndrome
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
This study is testing if a new treatment using nerve stimulation can help people who have ongoing fast heart rates and dizziness after recovering from COVID-19 by reducing inflammation in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | omalizumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05421208 on ClinicalTrials.gov |
What this trial studies
This study investigates the cardiovascular and immune mechanisms behind post-COVID-19 tachycardia syndrome, particularly focusing on patients who experience chronic tachycardia and orthostatic intolerance after recovering from COVID-19. It aims to test the hypothesis that reduced parasympathetic nervous system (PNS) activity is linked to persistent inflammation in these patients. The study will also explore whether restoring PNS function through chronic transcutaneous vagus nerve stimulation (tVNS) can alleviate symptoms of orthostatic intolerance and improve inflammatory markers. Participants will be monitored for changes in immune cell activation and symptom relief over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had a confirmed COVID-19 infection and are experiencing chronic tachycardia and orthostatic intolerance symptoms for more than three months.
Not a fit: Patients with significant heart disease, uncontrolled hypertension, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach for patients suffering from debilitating symptoms of post-COVID-19 tachycardia syndrome.
How similar studies have performed: While this approach is novel in the context of post-COVID-19 conditions, similar interventions targeting the vagus nerve have shown promise in other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Cyndya Shibao, M.D — Vanderbilt University Medical Center
- Study coordinator: Meena Vinayagam, M.D.
- Email: meenakshi.golchha@vumc.org
- Phone: 615-322-3447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.