Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
EMSICA
2 other identifiers
interventional
46
1 country
1
Brief Summary
The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 11, 2017
May 1, 2017
5.9 years
February 23, 2012
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VO2 peak
change between baseline and 60 days after the Functional Electromyo Stimulation
Secondary Outcomes (11)
Muscle nerve sympathetic activity (MSNA)
change between baseline and 60 days after the Functional Electromyo Stimulation
Six minutes walking test
change between baseline and 60 days after the Functional Electromyo Stimulation
DEXA
change between baseline and 60 days after the Functional Electromyo Stimulation
maximal quadriceps strengh
change between baseline and 60 days after the Functional Electromyo Stimulation
interleukin 1
change between baseline and 60 days after the Functional Electromyo Stimulation
- +6 more secondary outcomes
Study Arms (2)
Functionnal ElectroStimulation (FES)
EXPERIMENTALSHAM
SHAM COMPARATORInterventions
Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
Eligibility Criteria
You may qualify if:
- Advanced Chronic Heart Failure (NYHA III to IV)
- Cardiac Ejection Fraction \< 40 %
- peak VO2 \< 16 ml/kg/min,
- optimal drug treatment of CHF,
- hospitalised for acute decompensation but not in intensive care
You may not qualify if:
- Chronic Obstructive Pulmonary Disease with FEV \< 50%,
- History of stroke with walking disability, dementia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universty Hospital Toulouse Cardiology
Toulouse, 31059, France
Related Publications (1)
Labrunee M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.
PMID: 24265770RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel GALINIER, MD, PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
March 8, 2012
Study Start
July 1, 2008
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
May 11, 2017
Record last verified: 2017-05