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Low Level Tragus Stimulation in Acute Decompensated Heart Failure

Study acronym: TREAT-HF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 2026 → Dec 2026
See other at-risk trials from University of Oklahoma

Record History

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  1. Primary and study completion pushed from Sep 2026 to Dec 2026 Show 5 more changesShow less
    • Start date: Sep 2016 to Sep 16, 2016
    • Site contact updated
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria shortened, about 1 word
    • Collaborators expanded, about 3 words
  2. Primary and study completion dates: Sep 2025 to Sep 2026v12
  3. Primary and study completion dates: Sep 2024 to Sep 2025v11
  4. Primary and study completion dates: Sep 2023 to Sep 2024v10 Show 7 more changesShow less
    • Primary endpoints: 3 to 4
    • Enrollment target: 80 to 100
    • Interventions: Tragus stimulation (Device) to Neuromodulation (Device)
    • Eligibility criteria shortened, about 18 words
    • Study description expanded, about 275 words
    • Site contact updated
    • Secondary endpoints expanded, about 3 words
  5. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Sep 2021 to Sep 2023
    • Site details revised
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  2. Primary and study completion dates: Sep 2019 to Sep 2021v7
  3. Primary and study completion dates: Sep 2018 to Sep 2019v6
  4. Interventions: Tragus nerve stimulation (Device) to Tragus stimulation (Device)
    • Eligibility criteria shortened, about 16 words
    • Study title expanded, about 1 word
    v5
  5. Primary and study completion dates: Sep 2017 to Sep 2018
    • Study description shortened, about 1,536 words
    v4
  6. Site contact updated
    • Study description shortened, about 1 word
    v3
  7. Study description expanded, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 peptides, renal function and HRV in patients presenting with ADHF.
Trial Details
NCT Number NCT02898181
Lead Sponsor University of Oklahoma
Collaborators: Oklahoma Heart Hospital
Conditions
(from sponsor)		 Acute Decompensated Heart Failure
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov