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Clinical Trials/NCT01829607
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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Attikon Hospital
Responsible Party
Principal Investigator
Principal Investigator

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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