Epiphrenic III Pilot Trial | NCT01837771

Studies
Epiphrenic III Pilot Trial

NCT01837771

Sponsor

Luzerner Kantonsspital

Status

Unknown status

Last Update Posted

Apr 23, 2013Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Diaphragmatic stimulation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Mar 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 16, 2013

First Submission Date that Met QC Criteria

Apr 18, 2013

First Posted Date

Apr 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2013

Last Update Posted Date

Apr 23, 2013Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diaphragmatic stimulation	Active Comparator	Diaphragmatic stimulation via electrode for 4 weeks	Device: Diaphragmatic stimulation
No intervention	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diaphragmatic stimulation	Device		Diaphragmatic stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction		Four weeks
NYHA functional class		Four weeks

Secondary Outcomes

Measure	Description	Time Frame
Brain natriuretic peptide (BNP)		Four weeks
6-minutes walking test		Four weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul Erne, MD	Contact	++41 41 205 5208		paul.erne@luks.ch

Overall Officials

Name	Affiliation	Role
Paul Erne, MD	Luzerner Kantonsspital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Luzerner Kantonsspital	Recruiting	Lucerne	Canton of Lucerne	CH-6000	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided