Status:
COMPLETED
Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction
Lead Sponsor:
Attikon Hospital
Conditions:
Heart Failure With Preserved Left Ventricular Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of functional electrical stimulation of peripheral muscles on clinical and emotional status, endothelial function and left ventricular diastolic fu...
Eligibility Criteria
Inclusion
- (i) symptoms \[New York Heart Association (NYHA) class II or III\] and signs typical of heart failure
- (ii) left ventricular (LV) ejection fraction (LVEF) \>50% and LV end-diastolic volume index \<97 mL/m2
- (iii) findings of left atrial (LA) dilatation (LA volume index \>40mL/m2), LV hypertrophy and/or LV diastolic dysfunction \[ie, mitral E/A ratio \<1 or \>2, mitral E/e' ratio \>15 or 8-15, (A pulmonary - A mitral) duration difference \>30 ms etc)
- (iv) no alterations in medical therapy during the previous 4 weeks
- (v) no myocardial infarction within 3 months prior to enrollment
Exclusion
- recent (≤4 weeks) heart failure decompensation
- acute coronary syndrome
- chronic inflammatory diseases and malignancies
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01829607
Start Date
January 1 2011
Last Update
April 11 2013
Active Locations (1)
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1
Attikon University Hospital
Athens, Greece