NCT01837771

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

April 16, 2013

Last Update Submit

April 18, 2013

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Left ventricular ejection fraction

    Four weeks

  • NYHA functional class

    Four weeks

Secondary Outcomes (2)

  • Brain natriuretic peptide (BNP)

    Four weeks

  • 6-minutes walking test

    Four weeks

Study Arms (2)

Diaphragmatic stimulation

ACTIVE COMPARATOR

Diaphragmatic stimulation via electrode for 4 weeks

Device: Diaphragmatic stimulation

No intervention

NO INTERVENTION

Interventions

Diaphragmatic stimulationDEVICE
Diaphragmatic stimulation

Eligibility Criteria

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

You may qualify if:

  • Symptomatic heart failure (NYHA functional classes II, III or IV)
  • Reduced left ventricular ejection fraction (LVEF) \<35%
  • Guideline-recommended drug therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, CH-6000, Switzerland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Paul Erne, MD

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Erne, MD

CONTACT

++41 41 205 5208paul.erne@luks.ch

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
Head of Department of Cardiology

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 23, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

CH(1)