Status:
RECRUITING
Cardiovascular Autonomic and Immune Mechanism of Post COVID-19 Tachycardia Syndrome
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Post-acute COVID-19 Syndrome
Postural Tachycardia Syndrome (POTS)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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%)...
Detailed Description
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 fatigu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05421208
Start Date
June 1 2022
End Date
December 1 2026
Last Update
July 15 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232