Back to resultsEpiphrenic III Pilot Trial
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Diaphragmatic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Symptomatic heart failure (NYHA functional classes II, III or IV)
- Reduced left ventricular ejection fraction (LVEF) <35%
- Guideline-recommended drug therapy
Exclusion Criteria:
- Patient refuses study participation
- Life expectancy presumably <1 year
- Pregnancy
Sites / Locations
- Luzerner KantonsspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Diaphragmatic stimulation
No intervention
Arm Description
Diaphragmatic stimulation via electrode for 4 weeks
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
NYHA functional class
Secondary Outcome Measures
Brain natriuretic peptide (BNP)
6-minutes walking test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01837771
Brief Title
Epiphrenic III Pilot Trial
Official Title
Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
5. Study Description
Brief Summary
The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diaphragmatic stimulation
Arm Type
Active Comparator
Arm Description
Diaphragmatic stimulation via electrode for 4 weeks
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Diaphragmatic stimulation
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Time Frame
Four weeks
Title
NYHA functional class
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Brain natriuretic peptide (BNP)
Time Frame
Four weeks
Title
6-minutes walking test
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic heart failure (NYHA functional classes II, III or IV)
Reduced left ventricular ejection fraction (LVEF) <35%
Guideline-recommended drug therapy
Exclusion Criteria:
Patient refuses study participation
Life expectancy presumably <1 year
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Erne, MD
Phone
++41 41 205 5208
Email
paul.erne@luks.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
CH-6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Phone
++41 41 205 5208
Email
paul.erne@luks.ch
First Name & Middle Initial & Last Name & Degree
Andreas W Schoenenberger, MD
12. IPD Sharing Statement
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Epiphrenic III Pilot Trial
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