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NCT03327649 · ClinicalTrials.gov registry record · NA
Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction
A NA study of Heart Failure With Normal Ejection Fraction, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT03327649: Completed NA study of Heart Failure With Normal Ejection Fraction, sponsored by University of Oklahoma.
NCT03327649 is a NA study of Heart Failure With Normal Ejection Fraction that has completed, run by University of Oklahoma. The registered enrollment target is 52 participants, below the 634-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03327649, a NA study of Heart Failure With Normal Ejection Fraction, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to decrease morbidity or mortality. Recent animal and human studies suggest that a systemic proinflammatory state, produced by comorbidities, including aging, plays a central role in the development of HFpEF, supporting the notion that attenuating the proinflammatory state is an attractive therapeutic target for HFpEF. We have previously shown that low-level transcutaneous electrical stimulation of the vagus nerve (tVNS) suppresses inflammation in patients with atrial fibrillation. The overall objective of this proposal is to examine the effects of tVNS on diastolic dysfunction, exercise capacity and inflammation in patients with HFpEF. Our specific aims include: 1. To examine the effect of intermittent (1 hour daily for 3 months) tVNS on diastolic dysfunction and exercise capacity, relative to sham stimulation, in patients with HFpEF and 2. To examine the effect of intermittent (1 hour daily for 3 months) LLTS on inflammatory cytokines relative to sham stimulation, in patients with HFpEF. The proposed proof-of-concept studies will provide the basis for the design of further human studies using LLTS among populations with HFpEF. In light of the increasing number of elderly patients with HFpEF and the poor success of the currently available treatment options, an alternative and novel approach such as tVNS has the potential to impact clinical practice and improve health outcomes among a large number of patients. It is anticipated that these investigations will contribute to the broader understanding of the role of inflammation in the pathogenesis of HFpEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of inflammation affects one of the hallmarks of HFpEF, diastolic dysfunction, will lead to the
Primary Outcome
E/e' was measured by echocardiography. E/e' correlates very well with left ventricular end diastolic pressure. Higher numbers indicate elevated left ventricular end diastolic pressure.
Conditions Studied
Interventions
- DEVICE low level transcutaneous vagus nerve stimulation
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
What the finished NCT03327649 record still lists
NCT03327649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 634-participant average among 10 other Heart Failure With Normal Ejection Fraction trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Heart Failure With Normal Ejection Fraction appearing as the primary indexed condition, and to 1 intervention - of which low level transcutaneous vagus nerve stimulation is the first listed.
NCT03327649 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03327649 about?
NCT03327649 is a clinical study titled "Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction". Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to decrease morbidity or mortality. Recent animal and human studies suggest that a systemic proinflammatory state, p...
What is the current status of trial NCT03327649?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2017-12-12. Estimated completion is 2021-09-30.
What conditions does trial NCT03327649 study?
This clinical trial studies the following conditions: Heart Failure With Normal Ejection Fraction.
What interventions are being tested in trial NCT03327649?
The interventions under investigation include: low level transcutaneous vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT03327649?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03327649 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03327649's enrollment target sits among peer trials
52 8th of 10 higher than 3 of 10 other Heart Failure With Normal Ejection Fraction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Normal Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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