RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-01
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05421208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior RT-PCR-confirmed COVID-19 infection.
  2. * Post-COVID-19 POTS will be defined as the presence of orthostatic tachycardia (\>30 bpm) and chronic (\>3 months) pre-syncopal symptoms.
  1. * Heart Disease: Myocardial Infarction, angina, heart failure
  2. * History of stroke, or transient ischemic attack
  3. * Undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)
  4. * Uncontrolled hypertension defined as persistent blood pressure \>140/90.
  5. * Post-menopausal women.
  6. * Diabetes Mellitus Type 1 or Type 2. ,
  7. * Impaired Hepatic function
  8. * Impaired renal function test (eGFR\<60 mL/min/1.73m2).
  9. * Ongoing substance abuse.
  10. * Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study.
  11. * History of seizures.
  12. * Chronic use of steroids, NSAIDs.
  13. * On biologics such as anti-IL6 (omalizumab) and anti-TNF-alpha drugs
  14. * Pregnancy or breastfeeding

Contacts and Locations

Study Contact

Meena Vinayagam, M.D.
CONTACT
615-322-3447
meenakshi.golchha@vumc.org
Cyndya Shibao, MD
CONTACT
615-421-2998
cyndya.shibao@vumc.org

Principal Investigator

Cyndya Shibao, M.D
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Cyndya Shibao, M.D, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • SARS-CoV-2 infection

Additional Relevant MeSH Terms

  • Post-acute COVID-19 Syndrome
  • Postural Tachycardia Syndrome (POTS)
  • Long COVID
  • SARS CoV 2 Infection