Heart Failure With Reduced Ejection FractionTECO-HFNCT03945058
Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure
A study testing TVS in people with Heart Failure With Reduced Ejection Fraction, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- TVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- Patients in overt congestive heart failure / recent acute myocardial infarction (< 3 months) or Unstable angina
- Active malignancy
- Pre-menopausal women and post-menopausal women on hormone supplements.
- Unilateral or bilateral vagotomy
- Patients with bilateral upper extremity amputation
- Pregnant patients
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- 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 a body mass index (BMI) >35
- Significant hypotension (blood pressure <90mmHg) secondary to autonomic dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Effect of Neuromodulation on Inflammation, Endothelial Function and Cognitive Dysfunction in Patients With Heart Failure With Reduced Ejection Fraction
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.
Read the 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.
- Being tested
- TVS, SHAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVSDevice
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
SHAMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TVS; Device: SHAM |
| CONTROL | Sham comparator | 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. Receives: Device: TVS; Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation (FMD)
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.
Measured: Change in the brachial artery diameter will be compared to baseline change after 4 weeks of TVS or sham.
Laser Speckle Contrast Imaging (LSCI)
LSCI based perfusion index and perfusion units will be calculated before and after 4 weeks of TVS or sham stimulation.
Measured: Change in the perfusion units will be determined at baseline and after 4 weeks of TVS or sham stimulation.
EndoPAT
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.
Measured: Change in the reactive hyperemia index from baseline and after 4 weeks of TVS or SHAM stimulation
Pulse Wave Analysis (PWA)
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).
Measured: Change in the augmentation index will be calculated at baseline and after 4 weeks of TVS or sham stimulation.
Biomarkers of inflammation
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).
Measured: Change in these biomarkers(% change) over 4 weeks will be calculated.
Biomarkers of endothelial function and oxidative stress
Biomarkers of endothelial function and oxidative stress include: ORAC, HORAC scores expressed as %.
Measured: Change in these biomarkers(%) over 4 weeks will be calculated.
Secondary outcomes (1)
Cognition
Cognition score(%) calculated from Cambridge Neuropsychological Test Automated Battery -CANTAB method . This will be done using a hand held ipad.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start4 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Dec 2021
Why it stopped: Study was unable to meet target enrollment; no results generated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a pilot study that was terminated. The COVID pandemic prevented the enrollment of more participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taun Dasari, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945058
- Sponsor's protocol ID
- 10410T
- Acronym
- TECO-HF
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromodulation on Inflammation, Endothelial Function and Cognitive Dysfunction in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03945058
- Acronym / sponsor ID
- TECO-HF / 10410T
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was unable to meet target enrollment; no results generated.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a pilot study that was terminated. The COVID pandemic prevented the enrollment of more participants.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: TVS, Device: SHAMActive 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. |
| CONTROL | Sham comparator | Device: TVS, Device: SHAMSham 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%.
Key exclusion criteria (12 listed)
- Patients in overt congestive heart failure / recent acute myocardial infarction (< 3 months) or Unstable angina
- Active malignancy
- Pre-menopausal women and post-menopausal women on hormone supplements.
- Unilateral or bilateral vagotomy
- Patients with bilateral upper extremity amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVSActive 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 | CONTROL, Experimental |
| SHAMActive 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. | Device | CONTROL, Experimental |
Primary outcome
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.
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.
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.
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).
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).
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 %.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: Study was unable to meet target enrollment; no results generated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taun Dasari, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TVS in people with Heart Failure With Reduced Ejection Fraction, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was unable to meet target enrollment; no results generated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.