Trial Outcomes & Findings for Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction (NCT NCT03327649)
NCT ID: NCT03327649
Last Updated: 2026-01-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
3 months
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Sham Control
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction
Baseline characteristics by cohort
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=270 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=9 Participants
|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 9.1 • n=270 Participants
|
69.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
70.1 years
STANDARD_DEVIATION 8.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=270 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=270 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=270 Participants
|
24 participants
n=4 Participants
|
48 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 3 monthsE/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.
Outcome measures
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
E/e' (Early Mitral Inflow Doppler Velocity to the Early Diastolic Mitral Annulus Velocity)
|
10.4 ratio
Standard Deviation 1.5
|
9.9 ratio
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 3 monthsGlobal longitudinal strain was measured by echocardiography. It is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. Reduced global longitudinal strain has been associated with adverse clinical outcomes irrespective of left ventricular ejection fraction.
Outcome measures
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Global Longitudinal Strain
|
-16.1 percentage of myocardial shortening
Standard Deviation 2.5
|
-18.6 percentage of myocardial shortening
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 3 months6 minute walk test
Outcome measures
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Exercise Capacity
|
326.9 meters
Standard Deviation 140.4
|
352.7 meters
Standard Deviation 158.8
|
SECONDARY outcome
Timeframe: 3 monthsSerum inflammatory cytokines (tumor necrosis factor-alpha)
Outcome measures
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Inflammatory Cytokines
|
11.3 pg/mL
Standard Deviation 2.5
|
8.7 pg/mL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 3 monthsThe Minnesota Living with Heart Failure Questionnaire is a well validated measure of quality of life in patients with heart failure. It can have a score 0 to 105, with higher scores reflecting worse quality of life.
Outcome measures
| Measure |
Sham Control
n=24 Participants
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 Participants
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Minnesota Living With Heart Failure Questionnaire
|
36.6 units on a scale
Standard Deviation 14.8
|
23.8 units on a scale
Standard Deviation 14.8
|
Adverse Events
Sham Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Active Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Control
n=24 participants at risk
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
Active Treatment
n=24 participants at risk
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months
low level transcutaneous vagus nerve stimulation: Stimulation of the auricular branch of the vagus nerve
|
|---|---|---|
|
Cardiac disorders
hospitalization
|
12.5%
3/24 • Number of events 3 • 3 months
|
16.7%
4/24 • Number of events 4 • 3 months
|
Additional Information
Dr. Stavros Stavrakis
University of Oklahoma Health Sciences Center
Phone: 14052714742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place