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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure

Clinicaltrials.gov identifier NCT03945058

Recruitment Status Active, not recruiting

First Posted May 10, 2019

Last update posted April 10, 2020

Study Description

Brief summary:

Heart failure (HF) is the leading cause of death in US. It is associated with abnormal vascular function termed endothelial dysfunction. It is also associated with increased stress on the blood vessels and high levels of inflammation. Vagus nerve stimulation can help improve inflammation, vascular function and vascular stress. The investigator has recently completed a study showing that 1 hour of noninvasive vagus stimulation can improve vascular health. However, it is unknown if 4 weeks of stimulation will be beneficial in systolic heart failure. The purpose of this study is to determine if transcutaneous vagal stimulation (TVS) will lead to improvement in the function of the inner lining of participants' arteries, memory, and in the levels of certain chemical markers of arterial function in the blood. Participants will be randomized to receive either TVS or a sham stimulation and undergo 4 weeks of stimulation. Vascular function will be assessed by several non-invasive measurements, including Flow Mediate Dilation (FMD), Pulse Wave Analysis (PWA), EndoPAT, and Laser Speckle Contrast Imaging (LSCI). Participants' memory will also be measured through electronic assessments and blood will be collected and analyzed for arterial function chemical markers.

  • Condition or Disease:Heart Failure With Reduced Ejection Fraction
  • Intervention/Treatment: Device: TVS
    Device: SHAM
  • Phase: N/A
Detailed Description

Visit 1: Following tests(to assess vascular function) will be done: 1. FMD 2) LSCI 3) EndoPAT and 4) Pulse wave analysis (PWA). Patients will rest for 10 minutes between each test. They will be trained to use PARASYMTM unit for TVS. Blood collected, serum/plasma will be stored at -80F. Whole blood will be collected in PAXgene tubes. Patients will be instructed to apply TVS to either ear lobule (SHAM) or Tragus(experimental arm). Baseline characteristics will be collected including data on ventricular function(LVEF and left ventricular volumes). Visit 2 (4 weeks): Follow up tests(FMD,LSCI,EndoPAT,PWA) and repeat blood collection. Inflammatory cytokines and vascular function assays will be performed.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effect of Neuromodulation on Inflammation, Endothelial Function and Cognitive Dysfunction in Patients With Heart Failure With Reduced Ejection Fraction
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Sham Comparator: CONTROL
Sham TVS will be performed by use of a Tragus stimulator device with electrodes attached to the ear lobule. Stimulator will be applied continuously for 1 hour daily for 4weeks.
Device: TVS
Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 4 weeks

Device: SHAM
Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the earl lobule. Stimulator will be applied continuously for 1 hour daily for 4 weeks.
Experimental: Experimental
Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 4 weeks.
Device: TVS
Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 4 weeks

Device: SHAM
Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the earl lobule. Stimulator will be applied continuously for 1 hour daily for 4 weeks.
Outcome Measures
  • Primary Outcome Measures: 1. Flow Mediated Dilation (FMD) [ Time Frame: Change in the brachial artery diameter will be compared to baseline change after 4 weeks of TVS or sham. ]
    FMD is a change in the maximal diameter of the brachial artery. Brachial artery diameter (in millimeters) will be assessed before and after 4 weeks of stimulation using standard ultrasound.
  • 2. Laser Speckle Contrast Imaging (LSCI) [ Time Frame: Change in the perfusion units will be determined at baseline and after 4 weeks of TVS or sham stimulation. ]
    LSCI based perfusion index and perfusion units will be calculated before and after 4 weeks of TVS or sham stimulation.
  • 3. EndoPAT [ Time Frame: Change in the reactive hyperemia index from baseline and after 4 weeks of TVS or SHAM stimulation ]
    Hyperemia index measured with ENDOPAT will be calculated before and after 4 weeks of TVS. Hyperemia index will be calculated using the standard ENDOPAT technique using probes placed on bilateral finger.
  • 4. Pulse Wave Analysis (PWA) [ Time Frame: Change in the augmentation index will be calculated at baseline and after 4 weeks of TVS or sham stimulation. ]
    Arterial elasticity. Augmentation pressure (AP) will be calculated which is expressed as a percentage of the aortic pulse pressure (PP) which is the difference of systolic and diastolic BP(mm Hg).
  • 5. Biomarkers of inflammation [ Time Frame: Change in these biomarkers(% change) over 4 weeks will be calculated. ]
    Inflammatory cytokines will assayed at baseline and after 4 weeks of stimulation. Cytokines assayed : Il1B,IL-6,IL-17,TNF-a,TGF-b,CRP etc- expressed in pg/ml units).
  • 6. Biomarkers of endothelial function and oxidative stress [ Time Frame: Change in these biomarkers(%) over 4 weeks will be calculated. ]
    Biomarkers of endothelial function and oxidative stress include: ORAC, HORAC scores expressed as %.
  • Secondary Outcome Measures: 1. Cognition [ Time Frame: Change in the cognition score , as assessed by the CANTAB method will be compared at baseline and after 4 weeks of TVS or sham stimulation. ]
    Cognition score(%) calculated from Cambridge Neuropsychological Test Automated Battery -CANTAB method . This will be done using a hand held ipad.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 85 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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 Criteria: 1. Patients in overt congestive heart failure / recent acute myocardial infarction (35

12. Significant hypotension (blood pressure <90mmHg) secondary to autonomic dysfunction

Contacts and Locations
Contacts
Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator: Taun Dasari, MD OUHSC

More Information
  • Responsible Party: University of Oklahoma
  • ClinicalTrials.gov Identifier: NCT03945058 History of Changes
  • Other Study ID Numbers: 10410
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: April 10, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Heart Failure Inflammation