Other Clinical Trial - Neuromodulation of Inflammation & Vascular Function

Status Terminated

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Heart Failure
Heart Failure With Reduced Ejection Fraction
Inflammation

Clinical Trial Details

NCT number	NCT03945058
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Terminated
Phase	N/A
Start date	February 4, 2020
Completion date	December 16, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05077293` - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Completed	`NCT03614169` - Direct HIS-pacing as an Alternative to BiV-pacing in Symptomatic HFrEF Patients With True LBBB	N/A
Recruiting	`NCT05278962` - HF Patients With LVADs Being Treated With SGLT2i	Phase 4
Completed	`NCT04210375` - Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)	Phase 1
Not yet recruiting	`NCT06433687` - Evaluation of the HekaHeart Platform in Medication Management for Heart Failure Patients
Completed	`NCT05001165` - Dashboard Activated Services and Tele-Health for Heart Failure	N/A
Active, not recruiting	`NCT03701880` - Early Use of Ivabradine in Heart Failure	N/A
Recruiting	`NCT05650658` - Left vs Left Randomized Clinical Trial	N/A
Not yet recruiting	`NCT06299436` - Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Recruiting	`NCT05992116` - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Recruiting	`NCT05365568` - Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study	N/A
Active, not recruiting	`NCT05204238` - Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
Not yet recruiting	`NCT04420065` - Effects of Preferential Left Ventricular Pacing on Ventriculoarterial Coupling and Clinical Course of Heart Failure	N/A
Terminated	`NCT03479424` - Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
Completed	`NCT02113033` - VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients	Phase 2
Recruiting	`NCT03209180` - Immediate Release Versus Slow Release Carvedilol in Heart Failure	Phase 4
Recruiting	`NCT05299879` - Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study
Recruiting	`NCT05637853` - Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction
Completed	`NCT03870074` - CPET Predicts Long-term Survival and Positive Response to CRT
Recruiting	`NCT04590001` - Effect of the MobiusHD® in Patients With Heart Failure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure — TECO-HF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms