NCT01829607
Completed
Phase 2
Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction
Attikon Hospital1 site in 1 country30 target enrollmentJanuary 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Left Ventricular Ejection Fraction
- Sponsor
- Attikon Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Exercise capacity
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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 function in heart failure with preserved left ventricular ejection fraction.
Investigators
John Parissis
Assistant Professor of Cardiology
Attikon Hospital
Eligibility Criteria
Inclusion Criteria
- •(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 Criteria
- •recent (≤4 weeks) heart failure decompensation
- •acute coronary syndrome
- •chronic inflammatory diseases and malignancies
Outcomes
Primary Outcomes
Exercise capacity
Time Frame: Six weeks
Quality of life
Time Frame: Six weeks
Emotional status
Time Frame: Six weeks
Secondary Outcomes
- Left ventricular diastolic function(Six weeks)
- Endothelial function(Six weeks)
Study Sites (1)
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