Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT00769678
• Lead Sponsor: Luzerner Kantonsspital

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).

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2012-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients following open heart surgery who need permanent pacing

Exclusion Criteria

• Patients with fast changing need of vasopressors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	One day

Secondary Outcome Measures

Name	Time	Method
Brain natriuretic peptide (BNP)	One day
6-minutes walking distance	One day
NYHA functional class	One day

Trial Locations

Locations (1)

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland