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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure With Preserved Left Ventricular Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Functional electrical stimulation

Functional electrical stimulation of lower limbs

Group Type ACTIVE_COMPARATOR

Functional electrical stimulation of peripheral muscles

Intervention Type OTHER

Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Functional electrical stimulation of peripheral muscles

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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John Parissis

Assistant Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Attikon University Hospital

Athens, , Greece

Site Status

Countries

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Greece

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.

Reference Type DERIVED
PMID: 24093858 (View on PubMed)

Other Identifiers

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FES-HFPEF

Identifier Type: -

Identifier Source: org_study_id

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