Status:
COMPLETED
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function and Arterial Stiffness in HFrEF
Lead Sponsor:
University of Oklahoma
Conditions:
Heart Failure With Reduced Ejection Fraction
Endothelial Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Heart failure (HF) is the leading cause of hospitalization in the US. Endothelial dysfunction, characterized by the decreased vasodilatory capacity of the vascular endothelium, is rampant in atheroscl...
Eligibility Criteria
Inclusion
- 1\. Patients (18 years or older) with Heart failure with reduced ejection fraction (HFrEF), which is a history of symptomatic heart failure with left ventricular ejection fraction (LVEF) of \< 40%.
Exclusion
- patients in overt congestive heart failure / recent acute myocardial infarction (\< 3 months) or Unstable angina
- Active malignancy
- Perimenopausal women and post-menopausal women on hormone supplements.
- unilateral or bilateral vagotomy
- Patients with bilateral upper extremity amputation
- pregnant patients
- End-stage renal disease
- End-stage liver disease
- history of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular (AV) block.
- patients with clinically documented upper extremity arterial disease
- patients with BMI\>34
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03380156
Start Date
December 4 2017
End Date
May 30 2020
Last Update
January 14 2021
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117