NCT00769678

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3.6 years

First QC Date

October 3, 2008

Last Update Submit

April 16, 2013

Conditions

Heart Failure

Keywords

Biventricular Pacing

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    One day

Secondary Outcomes (3)

  • Brain natriuretic peptide (BNP)

    One day

  • 6-minutes walking distance

    One day

  • NYHA functional class

    One day

Study Arms (1)

Stimulation of diaphragm

ACTIVE COMPARATOR
Device: Stimulation of the diaphragm

Interventions

Stimulation of the diaphragmDEVICE

Stimulation of the diaphragm using an electrode

Stimulation of diaphragm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients following open heart surgery who need permanent pacing

You may not qualify if:

  • Patients with fast changing need of vasopressors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.

    PMID: 24464736DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Paul Erne

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2012

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CH(1)