Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction
Heart Failure With Normal Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring heart failure with preserved ejection fraction, inflammation
Eligibility Criteria
Inclusion Criteria:
HFpEF, defined as signs and symptoms of heart failure, LV ejection fraction ≥50%, brain natriuretic peptide ≥35pg/mL and echocardiographic evidence of diastolic dysfunction (left atrial volume index ≥34mL/m2, mitral E-wave velocity/mitral annular velocity ratio [E/e']≥13 and e'<9cm/s) plus 2 of the following 4 comorbidities:
- age ≥ 65,
- diabetes,
- hypertension and
- obesity, defined as body mass index ≥30kg/m2
Exclusion Criteria:
- LV ejection fraction <40%
- significant valvular disorder (i.e., prosthetic valve or hemodynamically significant valvular diseases)
- recent (<6 months) stroke, myocardial infarction or hospitalization for heart failure
- severe heart failure (class III or IV)
- end stage kidney disease
- recurrent vasovagal syncope
- history of vagotomy
- pregnancy
- sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker).
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Sham control
Active treatment
Patients will receive 1 hour of sham transcutaneous low level vagal stimulation daily for 3 months
Patients will receive 1 hour of active transcutaneous low level vagal stimulation daily for 3 months