Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IL-6 levels
研究概览
简要总结
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
详细描述
Post-acute sequelae of COVID-19 infection or Long COVID is a growing concern, even in patients with mild initial illness. These patients develop numerous chronic debilitating symptoms including fatigue, chest pain, reduced exercise tolerance and tachycardia, with symptoms persisting weeks beyond the initial infection.
Preliminary data shows that post-COVID-19 POTS patients have reduced parasympathetic (PNS) function. Given that the PNS protects against inflammation, it is hypothesize that post-COVID-19 POTS is caused by reduced PNS activity, which in turn, contributes to persistent inflammation, orthostatic intolerance (OI) symptoms
Aim 1 of the study is to test the hypothesis that reduced PNS activity is associated with persistent inflammation in patients with post-COVID-19 POTS.
Aim 2: Test the hypothesis that restoring PNS function in post-COVID-19 POTS patients with chronic transcutaneous vagus nerve stimulation (tVNS) will improve inflammation, orthostatic tachycardia and OI symptoms.
Primary Outcome Measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
The POTS patients will be randomized to chronic transcutaneous vagus nerve stimulation (tVNS) in any of the two sites on ear, and there will 50% change to be allocated to one of the sites that may have less stimulation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/
- •Post-menopausal women.
- •Diabetes Mellitus Type 1 or Type
- •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
研究组 & 干预措施
Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.
Effects of restoring PNS function in post-COVID-19 POTS patients with chronic transcutaneous vagus nerve stimulation (tVNS) on inflammation, orthostatic tachycardia and OI symptoms.The subjects with POTS will be randomized, where TENS 7000 device will be placed to active and sham location.Autonomic symptoms assessment questionnaire (COMPASS-31),32 quality of life EQ-5D and neuropsychological tests
干预措施: Effect on inflammation after chronic PNS stimulation (Diagnostic Test)
Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
Biochemical endpoints: Measurement of Inflammatory markers (especially IL-6) in both Post- COVID-19 POTS patients and compare it with controls.
Controls are the participants who recovered from COVID 19 infection with no sequelae
干预措施: Levels of inflammatory cytokine ( IL-6) in controls (Diagnostic Test)
Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with Controls
Biochemical endpoints: Measurement of Inflammatory markers (especially IL-6) in both Post- COVID-19 POTS patients and compare it with controls.
Controls are the participants who recovered from COVID 19 infection with no sequelae
干预措施: Levels of inflammatory cytokine ( IL-6) in post-COVID-19 POTS and controls (Diagnostic Test)
结局指标
主要结局
IL-6 levels
时间窗: Baseline to after 28 days of tVNS stimulation
Evaluate immune cell activation in post-COVID-19 POTS and patients with history of COVID-19 infection without sequelae and correlate this with the degree of decreased PNS activity. The primary endpoint is IL-6 levels
次要结局
- Orthostatic Symptoms Score(Baseline to after 28 days of tVNS stimulation)
研究者
Cyndya Shibao, MD
Professor
Vanderbilt University Medical Center