Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome (NCT05421208) | Clinical Trial Compass
RecruitingNot Applicable
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
United States60 participantsStarted 2022-06-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IL-6 levels
Timeframe: Baseline to after 28 days of tVNS stimulation