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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829607
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
John Parissis, Attikon Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Left Ventricular Ejection Fraction Other: Functional electrical stimulation of peripheral muscles Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Functional electrical stimulation
Functional electrical stimulation of lower limbs
Other: Functional electrical stimulation of peripheral muscles
Placebo Comparator: Placebo



Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: Six weeks ]
  2. Quality of life [ Time Frame: Six weeks ]
  3. Emotional status [ Time Frame: Six weeks ]

Secondary Outcome Measures :
  1. Left ventricular diastolic function [ Time Frame: Six weeks ]
  2. Endothelial function [ Time Frame: Six weeks ]

Other Outcome Measures:
  1. Neurohormonal activation [ Time Frame: Six weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829607


Locations
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Greece
Attikon University Hospital
Athens, Greece
Sponsors and Collaborators
Attikon Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Parissis, Assistant Professor of Cardiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT01829607    
Other Study ID Numbers: FES-HFPEF
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases