Epiphrenic III Pilot Trial

Not Applicable

• Conditions: Heart Failure

• 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

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23
• Primary Completion: 2016-03

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

Exclusion Criteria

• Patient refuses study participation
• Life expectancy presumably <1 year
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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; 🇨🇭 Luzern, Switzerland