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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional electrical stimulation | Active Comparator | Functional electrical stimulation of lower limbs |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional electrical stimulation of peripheral muscles | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | Six weeks | |
| Quality of life | Six weeks | |
| Emotional status | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular diastolic function | Six weeks | |
| Endothelial function | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neurohormonal activation | Six weeks |
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University Hospital | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24093858 | Derived | 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. |
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