Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction
NCT ID: NCT01829607
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Functional electrical stimulation
Functional electrical stimulation of lower limbs
Functional electrical stimulation of peripheral muscles
Placebo
No interventions assigned to this group
Interventions
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Functional electrical stimulation of peripheral muscles
Eligibility Criteria
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Inclusion Criteria
(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
* acute coronary syndrome
* chronic inflammatory diseases and malignancies
18 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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John Parissis
Assistant Professor of Cardiology
Locations
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Attikon University Hospital
Athens, , Greece
Countries
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References
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Karavidas A, Driva M, Parissis JT, Farmakis D, Mantzaraki V, Varounis C, Paraskevaidis I, Ikonomidis I, Pirgakis V, Anastasiou-Nana M, Filippatos G. Functional electrical stimulation of peripheral muscles improves endothelial function and clinical and emotional status in heart failure patients with preserved left ventricular ejection fraction. Am Heart J. 2013 Oct;166(4):760-7. doi: 10.1016/j.ahj.2013.06.021. Epub 2013 Aug 30.
Other Identifiers
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FES-HFPEF
Identifier Type: -
Identifier Source: org_study_id
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