An interventional study of neuromodulation device and SHAM in Systolic Heart Failure, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 17th largest by planned enrollment of the 69 interventional ones that give a count, is one of 3 that started in 2022, is one of 44 with no phase, reaches primary completion later than 9 of the 20 other live ones, and was the 59th registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
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83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 158 is above the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
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24 of 83 have an industry lead sponsor. The 10 most frequent:
University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
University of Oklahoma has 1 study filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
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Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
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Heart failure with reduced ejection fraction (HFrEF) is a major cause of mortality in United States. Aging is a major risk factor for adverse outcomes associated with HFrEF, with majority of the patient's over the age of 50, continuing to experience symptoms, reduced exercise capacity and poor quality of life. We have previously demonstrated that low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) suppresses inflammation in patients with atrial fibrillation and diastolic dysfunction and improved endothelial dysfunction in patients with chronic heart failure. The overall objective of this proposal is to examine the effects of LLTS on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function. Our specific aims include: 1. To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2. To determine the effects of medium-term LLTS on sympathovagal/autonomic balance (assessed by heart rate variability) and systemic inflammation in patients with HFrEF and 3. To determine the effects of medium-term LLTS on endothelial function in patients with HFrEF. The proposed proof-of-concept human studies will provide the basis for the design of further human studies using LLTS among larger populations with HFrEF. In light of the increasing number of elderly patients who continue to experience HFrEF symptoms, recognized is a key point of interest in this funding mechanism, and the suboptimal success of the currently available treatment options to ameliorate the problems mentioned above, an alternative novel approach such as LLTS has the potential to impact clinical practice and improve health outcomes among the large number of patients. It is anticipated that these investigations will contribute to a broader understanding of the role of autonomic imbalance, inflammation and endothelial dysfunction in the pathogenesis of HFrEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of autonomic tone, inflammation and endothelial function affects one of the hallmarks of HFrEF will lead to the development of normal nonpharmacological and pharmacological approaches to treat this disease.
Prospective randomized double-blind study of Lowlevel Tragus stimulation-LLTS vs. sham treatment.
We will require n=108 participants (54 in each group) to reach statistical significance and to account for potential drop-out (anticipated \<5%, based on previous study in atrial fibrillation) from the study and 50 subjects below the age of 50 will be enrolled in the control group 2 for comparison purposes, for a total of 158 patients.
Aim 1:
Objective 1: measure the medium-term effects of LLTS on exercise capacity in subjects with HF - 6-minute walk distance (6MWD) will be performed at baseline and after 3 months of LLTS. Change in 6MWD from baseline to 3 months will be compared between experimental and sham groups. Duration of test: \<10 minutes. A dedicated quite hallway exists in the translational geroscience laboratory which will enable performance of the test. Study will be performed by the research coordinator.
Objective 2: assess the effects of medium-term LLTS on quality of life in subjects with HF - quality of life will be determined using standard HF questionnaire (MLWHF score). This questionnaire will be administered at baseline and after 3 months. Duration of test: \<15 minutes. Study will be administered by our research coordinator either on paper or tablet.
Aim2:
Objective 1: measure the effects of medium-term LLTS on sympathovagal balance in subjects with HF - Heart rate variability (HRV), a well-established, noninvasive measure of autonomic function, will be measured and analyzed via 10 min ECG using standard Labscribe and Kubios software. The amplitude and changes of the low (0.04-0.15Hz), high (0.15-0.4Hz) and the low frequency/high frequency ratio along with specific time domain variables (SDNN,SDANN,pNN50,rMSSD) will be determined to reflect autonomic imbalance.
Objective 2: assess the effects of medium-term LLTS stimulation on HF biomarkers, inflammation - using high sensitivity ELISA kits, NT-Pro BNP, sST2, Interleukins (6, 1), TNF-α, hsCRP will be assayed.
Aim 3:
Objective 1: assess the effects of medium-term LLTS on vascular endothelial function -Flow-mediated vasodilatation (FMD) will be used to assess %-change in brachial artery diameter upon the release of temporary 5-min blood flow occlusion to the extremity using ultrasonography (Phillips Affinity X70). This is a standard, validated technique to assess FMD. Average time to perform this study is \~20 minutes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Systolic heart failure with EF \< or equal to 50%.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active LLTS will be performed by use of a neuromodulation device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 12 weeks.
Device: neuromodulation device
Sham LLTS will be performed by use of a neuromodulation device with electrodes attached to the ear lobule. Stimulator will be applied continuously for 1 hour daily for 12 weeks.
Device: SHAM
Active LLTS will be performed by use of a neuromodulation device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 12 weeks
Sham LLTS will be performed by use of a neuromodulation device with electrodes attached to the ear lobule. Stimulator will be applied continuously for 1 hour daily for 12 weeks
6MWD
6 minute walk distance
Time frame: Change in 6MWD after 12 weeks compared to baseline
QoL
Quality of life will be assessed using the Minnesota living with heart failure questionnaire
Time frame: Change in QoL after 12 weeks compared to baseline
FMD
Flow mediated vasodilatation will be assessed using vascular ultrasound measuring brachial artery diameter change with standard 5 minute BP cuff occlusion test.
Time frame: Change in FMD after 12 weeks compared to baseline
HRV
heart rate variability
Time frame: Change in HRV after 12 weeks compared to baseline
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).
Time frame: Change in inflammatory markers after 12 weeks compared to baseline
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Feb 2027, 53 months after the start.
Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 53 months is above that.
Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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