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Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction

Primary Purpose

Heart Failure With Preserved Left Ventricular Ejection Fraction

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Functional electrical stimulation of peripheral muscles

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Left Ventricular Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Attikon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Functional electrical stimulation

Placebo

Arm Description

Functional electrical stimulation of lower limbs

Outcomes

Primary Outcome Measures

Exercise capacity

Quality of life

Emotional status

Secondary Outcome Measures

Left ventricular diastolic function

Endothelial function

Full Information

NCT ID

NCT01829607

First Posted

April 9, 2013

Last Updated

April 10, 2013

Sponsor

Attikon Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01829607

Brief Title

Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Attikon Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Preserved Left Ventricular Ejection Fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Functional electrical stimulation

Arm Type

Active Comparator

Arm Description

Functional electrical stimulation of lower limbs

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Functional electrical stimulation of peripheral muscles

Primary Outcome Measure Information:

Title

Exercise capacity

Time Frame

Six weeks

Title

Quality of life

Time Frame

Six weeks

Title

Emotional status

Time Frame

Six weeks

Secondary Outcome Measure Information:

Title

Left ventricular diastolic function

Time Frame

Six weeks

Title

Endothelial function

Time Frame

Six weeks

Other Pre-specified Outcome Measures:

Title

Neurohormonal activation

Time Frame

Six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Attikon University Hospital

City

Athens

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

24093858

Citation

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.

Results Reference

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Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction

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