Back to resultsStimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stimulation of the diaphragm
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Biventricular Pacing
Eligibility Criteria
Inclusion Criteria:
- Patients following open heart surgery who need permanent pacing
Exclusion Criteria:
- Patients with fast changing need of vasopressors
Sites / Locations
- Kantonsspital Luzern
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Stimulation of diaphragm
Arm Description
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
Secondary Outcome Measures
Brain natriuretic peptide (BNP)
6-minutes walking distance
NYHA functional class
Full Information
NCT ID
NCT00769678
First Posted
October 3, 2008
Last Updated
April 16, 2013
Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
1. Study Identification
Unique Protocol Identification Number
NCT00769678
Brief Title
Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery
Official Title
Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
4. Oversight
5. Study Description
Brief Summary
This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.
Detailed Description
Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Biventricular Pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulation of diaphragm
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Stimulation of the diaphragm
Intervention Description
Stimulation of the diaphragm using an electrode
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Time Frame
One day
Secondary Outcome Measure Information:
Title
Brain natriuretic peptide (BNP)
Time Frame
One day
Title
6-minutes walking distance
Time Frame
One day
Title
NYHA functional class
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients following open heart surgery who need permanent pacing
Exclusion Criteria:
Patients with fast changing need of vasopressors
Facility Information:
Facility Name
Kantonsspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24464736
Citation
Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.
Results Reference
derived
Learn more about this trial
Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery
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