Mechanisms of Post COVID-19 Tachycardia Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Must not be taking: Steroids, NSAIDs, Biologics
Disqualifiers: Heart disease, Stroke, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a device that sends mild electrical signals to the ear to help people with long-term symptoms after COVID-19. It focuses on those who have ongoing issues like a fast heartbeat and dizziness. The device aims to reduce inflammation and improve these symptoms by stimulating a nerve that helps control these functions.
Will I have to stop taking my current medications?
The trial requires that participants do not use certain medications, such as chronic steroids, NSAIDs (non-steroidal anti-inflammatory drugs), and biologics like anti-IL6 and anti-TNF-alpha drugs. If you are taking these, you may need to stop before joining the trial.
What data supports the effectiveness of this treatment for post-COVID-19 tachycardia syndrome?
The research suggests that post-COVID-19 patients with symptoms like tachycardia (fast heart rate) and orthostatic intolerance (difficulty standing up without feeling dizzy) may benefit from treatments that include heart rate-lowering medications and lifestyle changes, such as increasing salt and fluid intake. These approaches have shown potential in managing similar symptoms in non-COVID-related conditions.
12345Is the treatment for post-COVID-19 tachycardia syndrome safe for humans?
The studies reviewed focus on understanding heart rate variability and autonomic nervous system function in post-COVID-19 patients, but they do not provide specific safety data for a treatment. They suggest that the effects of COVID-19 on heart function may decrease over time, but no direct safety information about a treatment is available.
23678How does the treatment for post-COVID-19 tachycardia syndrome differ from other treatments?
The treatment for post-COVID-19 tachycardia syndrome is unique because it focuses on addressing autonomic dysfunction, which is a key factor in this condition. Unlike standard treatments, it may involve a combination of lifestyle changes, heart rate-lowering medications like ivabradine or β-blockers, and supportive measures such as compression stockings and increased salt and fluid intake. This approach is tailored to manage the specific symptoms and underlying mechanisms associated with post-COVID-19 autonomic dysfunction.
12359Eligibility Criteria
This trial is for individuals who previously had COVID-19 and now suffer from a condition called post-COVID-19 POTS, characterized by rapid heartbeat when standing up and symptoms like dizziness lasting over 3 months. It's not for those with heart disease, on certain medications like steroids or biologics, post-menopausal women, pregnant or breastfeeding people, those with liver issues, seizure history, recent cardiovascular procedures, substance abuse problems, severe mental conditions, stroke history or impaired kidney function.Inclusion Criteria
You have previously tested positive for COVID-19 using a specific test called RT-PCR.
I have had a fast heart rate and near-fainting for over 3 months after COVID-19.
I have had a fast heart rate and near-fainting for over 3 months after COVID-19.
+1 more
Exclusion Criteria
I have had seizures in the past.
I have diabetes (Type 1 or Type 2).
I am currently taking medications like omalizumab or anti-TNF-alpha drugs.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive chronic transcutaneous vagus nerve stimulation (tVNS) for 28 days
4 weeks
3 visits (in-person), 1 visit (telemedicine)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study investigates the role of inflammation in long-term rapid heartbeat after COVID-19 (post-COVID-19 POTS). Researchers are measuring levels of an inflammatory marker (IL-6) and examining the effects of chronic stimulation of the parasympathetic nervous system to reduce inflammation in affected patients compared to healthy controls.
2Treatment groups
Experimental Treatment
Group I: Effect of OI symptoms & inflmmation after Restoring PNS functions in post-COVID POTS patients.Experimental Treatment1 Intervention
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
Group II: Compare inflammatory markers (IL-6) in post- COVID 19 POTS patients with ControlsExperimental Treatment2 Interventions
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
American Heart AssociationCollaborator
References
Postural orthostatic tachycardia syndrome (POTS) and other autonomic disorders after COVID-19 infection: a case series of 20 patients. [2021]To describe clinical features, diagnostic findings, treatments, and outcomes in patients with new-onset postural orthostatic tachycardia syndrome (POTS) and other autonomic disorders following SARS-CoV-2 infection (COVID-19).
Observational case series of postural tachycardia syndrome (PoTS) in post-COVID-19 patients. [2022]There is emerging evidence that a proportion of patients who develop long (post)-COVID-19 have abnormalities in the regulation of their autonomic nervous system manifesting as postural tachycardia syndrome (PoTS). We report a series of 14 patients who developed symptoms and signs compatible with PoTS following clinically diagnosed COVID-19 infection. Their symptoms and clinical findings were consistent with those of patients with non-COVID-related PoTS. The authors recommend an active stand test for patients who present after COVID-19 infection with cardiovascular symptoms including chest pain, palpitations, lightheadedness and breathlessness that are worse with the upright posture. They further recommend training of clinicians and investment in health services to provide for the anticipated significant increase in patients presenting with PoTS and other forms of autonomic dysfunction due to the COVID-19 pandemic.
Investigating autonomic nervous system dysfunction among patients with post-COVID condition and prolonged cardiovascular symptoms. [2023]Heart Rate Variability (HRV) and arterial pressure (AP) variability and their responses to head-up tilt test (HUTT) were investigated in Post-COVID-19 syndrome (PCS) patients reporting tachycardia and/or postural hypotension. Besides tachycardia, PCS patients also showed attenuation of the following HRV parameters: RMSSD [square root of the mean of the sum of the squares of differences between adjacent normal-to-normal (NN) intervals] from statistical measures; the power of RR (beat-to-beat interval) spectra at HF (high frequency) from the linear method spectral analysis; occurrence of 2UV (two unlike variation) pattern of RR from the nonlinear method symbolic analysis; and the new family of statistics named sample entropy, when compared to control subjects. Basal AP and LF (low frequency) power of systolic AP were similar between PCS patients and control subjects, while 0 V (zero variation) patterns of AP from the nonlinear method symbolic analysis were exacerbated in PCS patients. Despite tachycardia and a decrease in RMSSD, no parameter of HRV changed during HUTT in PCS patients compared to control subjects. PCS patients reassessed after 6 months showed higher HF power of RR spectra and a higher percentage of 2UV pattern of RR. Moreover, the reassessed PCS patients showed a lower occurrence of 0 V patterns of AP, while the HUTT elicited HR (heart rate) and AP responses identical to control subjects. The HRV and AP variability suggest an autonomic dysfunction with sympathetic predominance in PCS patients. In contrast, the lack of responses of HRV and AP variability indices during HUTT indicates a marked impairment of autonomic control. Of note, the reassessment of PCS patients showed that the noxious effect of COVID-19 on autonomic control tended to fade over time.
Altered cardiac autonomic function after recovery from COVID-19. [2023]Autonomic dysfunction may occur during the acute phase of COVID-19. Heart rate variability (HRV) is a useful tool for the assessment of cardiac sympathetic and parasympathetic balance. We aimed to evaluate cardiac autonomic function by using HRV in subjects after recovery from COVID-19 who had previously symptomatic and were followed outpatiently.
Postural orthostatic tachycardia syndrome as a sequela of COVID-19. [2023]Postural orthostatic tachycardia syndrome (POTS) is a complex multisystem disorder characterized by orthostatic intolerance and tachycardia and may be triggered by viral infection. Recent reports indicate that 2%-14% of coronavirus disease 2019 (COVID-19) survivors develop POTS and 9%-61% experience POTS-like symptoms, such as tachycardia, orthostatic intolerance, fatigue, and cognitive impairment within 6-8 months of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Pathophysiological mechanisms of post-COVID-19 POTS are not well understood. Current hypotheses include autoimmunity related to SARS-CoV-2 infection, autonomic dysfunction, direct toxic injury by SARS-CoV-2 to the autonomic nervous system, and invasion of the central nervous system by SARS-CoV-2. Practitioners should actively assess POTS in patients with post-acute COVID-19 syndrome symptoms. Given that the symptoms of post-COVID-19 POTS are predominantly chronic orthostatic tachycardia, lifestyle modifications in combination with the use of heart rate-lowering medications along with other pharmacotherapies should be considered. For example, ivabradine or β-blockers in combination with compression stockings and increasing salt and fluid intake has shown potential. Treatment teams should be multidisciplinary, including physicians of various specialties, nurses, psychologists, and physiotherapists. Additionally, more resources to adequately care for this patient population are urgently needed given the increased demand for autonomic specialists and clinics since the start of the COVID-19 pandemic. Considering our limited understanding of post-COVID-19 POTS, further research on topics such as its natural history, pathophysiological mechanisms, and ideal treatment is warranted. This review evaluates the current literature available on the associations between COVID-19 and POTS, possible mechanisms, patient assessment, treatments, and future directions to improving our understanding of post-COVID-19 POTS.
The Cardiac Comeback-Beating Stronger: Exploring the Remarkable Resilience of the Heart in COVID-19 Recovery through Cardiac Autonomic Analysis. [2023]Background and Objectives: Analyzing the cardiac autonomic function in COVID-19 patients can provide insights into the impact of the virus on the heart's regulatory mechanisms and its recovery. The autonomic nervous system plays a crucial role in regulating the heart's functions, such as heart rate, blood pressure, and cardiac output. This study aimed to investigate the impact of COVID-19 on heart rate variability (HRV) during a 6-min walk test (6MWT). Materials and Methods: The study included 74 participants, consisting of 37 individuals who had recovered from mild to moderate COVID-19 and 37 healthy controls. The study assessed heart rate variability (HRV) and blood pressure both before and after a 6-min walk test (6MWT). Results: The study found significant differences in a few time domains (SDNN and pNN50) and all frequency domain measures, whereas there were no significant differences in demographic characteristics or blood pressure between COVID-19-recovered individuals and healthy controls at rest. There were significant 6MWT effects on average HR, time-domain (SDNN and pNN50) measures of HRV, and all frequency domain measures of HRV. A significant group × 6MWT interaction was found for SDNN, pNN50, total power, Ln total power, LF, HF, Ln LF, Ln HF, and LF nu. Conclusions: Cardiac Autonomic analysis through HRV is essential to ensure the continued health and well-being of COVID-19 survivors and to minimize the potential long-term impacts of the disease on their cardiovascular system. This suggests that HRV analysis during the recovery phase following exercise could serve as a valuable tool for evaluating the physiological effects of COVID-19 and monitoring the recovery process.
Network autonomic analysis of post-acute sequelae of COVID-19 and postural tachycardia syndrome. [2022]The autonomic nervous system (ANS) is a complex network where sympathetic and parasympathetic domains interact inside and outside of the network. Correlation-based network analysis (NA) is a novel approach enabling the quantification of these interactions. The aim of this study is to assess the applicability of NA to assess relationships between autonomic, sensory, respiratory, cerebrovascular, and inflammatory markers on post-acute sequela of COVID-19 (PASC) and postural tachycardia syndrome (POTS).
Heart rate variability as a marker of cardiovascular dysautonomia in post-COVID-19 syndrome using artificial intelligence. [2022]Cardiovascular dysautonomia comprising postural orthostatic tachycardia syndrome (POTS) and orthostatic hypotension (OH) is one of the presentations in COVID-19 recovered subjects. We aim to determine the prevalence of cardiovascular dysautonomia in post COVID-19 patients and to evaluate an Artificial Intelligence (AI) model to identify time domain heart rate variability (HRV) measures most suitable for short term ECG in these subjects.
Autonomic Nerve Involvement in Post-Acute Sequelae of SARS-CoV-2 Syndrome (PASC). [2023]The novel SARS-CoV-2 virus and resulting COVID-19 global pandemic emerged in 2019 and continues into 2022. While mortality from COVID-19 is slowly declining, a subset of patients have developed chronic, debilitating symptoms following complete recovery from acute infection with COVID-19. Termed as post-acute sequelae of SARS-CoV-2 syndrome (PASC), the underlying pathophysiology of PASC is still not well understood. Given the similarity between the clinical phenotypes of PASC and postural orthostatic tachycardia syndrome (POTS), it has been postulated that dysautonomia may play a role in the pathophysiology of PASC. However, there have been only a few studies that have examined autonomic function in PASC. In this retrospective study, we performed an analysis of autonomic nerve function testing in PASC patients and compared the results with those of POTS patients and healthy controls. Our results suggest that a significant number of PASC patients have abnormal autonomic function tests, and their clinical features are indistinguishable from POTS.