Epiphrenic III Pilot Trial
Not Applicable
- Conditions
- Heart Failure
- Interventions
- Device: Diaphragmatic stimulation
- Registration Number
- NCT01837771
- Lead Sponsor
- Luzerner Kantonsspital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Symptomatic heart failure (NYHA functional classes II, III or IV)
- Reduced left ventricular ejection fraction (LVEF) <35%
- Guideline-recommended drug therapy
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Exclusion Criteria
- Patient refuses study participation
- Life expectancy presumably <1 year
- Pregnancy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Diaphragmatic stimulation Diaphragmatic stimulation Diaphragmatic stimulation via electrode for 4 weeks
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction Four weeks NYHA functional class Four weeks
- Secondary Outcome Measures
Name Time Method Brain natriuretic peptide (BNP) Four weeks 6-minutes walking test Four weeks
Trial Locations
- Locations (1)
Luzerner Kantonsspital
🇨ðŸ‡Luzern, Switzerland