Epiphrenic III Pilot Trial

Heart Failure Clinical Trial

Official title:

Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01837771
• Other study ID #: 13008
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2013
• Last updated: April 18, 2013
• Start date: April 2013

Study information

• Verified date: April 2013
• Source: Luzerner Kantonsspital
• Contact: Paul Erne, MD
• Phone: ++41 41 205 5208
• Email: paul.erne[@]luks.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Diaphragmatic stimulation

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		Four weeks	No
Primary	NYHA functional class		Four weeks	No
Secondary	Brain natriuretic peptide (BNP)		Four weeks	No
Secondary	6-minutes walking test		Four weeks	No