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NCT05230732 · ClinicalTrials.gov registry record · NA
Neuromodulation of Inflammation and Endothelial Function
A NA study of Systolic Heart Failure, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- NA
- Development phase
- 158
- Enrollment target
- 1
- Study location
NCT05230732 is a NA study of Systolic Heart Failure that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 158 participants, above the 84-participant average among 3 other Systolic Heart Failure trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05230732, a NA study of Systolic Heart Failure, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- NA
- Development phase
- 158 participants
- Enrollment target
- 1
- Study location
Study Summary
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 co
Conditions Studied
Interventions
- DEVICE neuromodulation device
- DEVICE SHAM
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2026-02-27 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05230732
The ClinicalTrials.gov registry entry for NCT05230732 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 84-participant average among 3 other Systolic Heart Failure trials with a reported enrollment target (88% higher). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systolic Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which neuromodulation device is the first listed.
NCT05230732 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05230732 about?
NCT05230732 is a clinical study titled "Neuromodulation of Inflammation and Endothelial Function". 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 quali...
What is the current status of trial NCT05230732?
This trial is currently recruiting. It is a NA study. The enrollment target is 158 participants. The study started on 2022-09-01. Estimated completion is 2026-02-27.
What conditions does trial NCT05230732 study?
This clinical trial studies the following conditions: Systolic Heart Failure.
What interventions are being tested in trial NCT05230732?
The interventions under investigation include: neuromodulation device (DEVICE), SHAM (DEVICE).
Who is sponsoring clinical trial NCT05230732?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05230732 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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