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NCT02898181 · ClinicalTrials.gov registry record · NA
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
A NA study of Acute Decompensated Heart Failure, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT02898181 is a NA study of Acute Decompensated Heart Failure that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 100 participants, below the 451-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02898181, a NA study of Acute Decompensated Heart Failure, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation. Previous studies have demonstrated increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation is thought to increase the parasympathetic activity and suppress the sympathetic activity. Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1, IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10. heart rate variability may also be abnormal in ADHF. The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines, heart failure biomarkers(Pro BNP) and HRV in patients with ADHF.In addition we will study the impact on dyspnea resolution and change in renal function during hospitalization. Patients will be randomized to either active or sham stimulation (2 hours daily). Serum collected will (post-admission and discharge day) will be used for cytokine measurement. We will also measure daily ECG to assess HRV and patient assessed dyspnea scale.This investigation will likely establish the first evidence of the effects of LLTS on the suppression of inflammation and improvement in dyspnea, natriuretic pe
Conditions Studied
Interventions
- DEVICE Neuromodulation
Study Locations (1)
Oklahoma
- OUHSC - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-09 |
| Est. Completion | 2026-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02898181
The ClinicalTrials.gov registry entry for NCT02898181 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 451-participant average among 12 other Acute Decompensated Heart Failure trials with a reported enrollment target (78% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Decompensated Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Neuromodulation is the first listed.
NCT02898181 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT02898181 about?
NCT02898181 is a clinical study titled "Low Level Tragus Stimulation in Acute Decompensated Heart Failure". Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation. Previous studies have demonstrated increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (...
What is the current status of trial NCT02898181?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2016-09. Estimated completion is 2026-09.
What conditions does trial NCT02898181 study?
This clinical trial studies the following conditions: Acute Decompensated Heart Failure.
What interventions are being tested in trial NCT02898181?
The interventions under investigation include: Neuromodulation (DEVICE).
Who is sponsoring clinical trial NCT02898181?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02898181 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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