Status:
COMPLETED
Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of Oklahoma
Conditions:
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief 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 morb...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03327649
Start Date
December 12 2017
End Date
September 30 2021
Last Update
September 22 2022
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104