Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epiphrenic III Pilot Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837771
Recruitment Status : Unknown
Verified April 2013 by Prof. Paul Erne, Luzerner Kantonsspital.
Recruitment status was:  Recruiting
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Diaphragmatic stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)
Study Start Date : April 2013
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Diaphragmatic stimulation
Diaphragmatic stimulation via electrode for 4 weeks
Device: Diaphragmatic stimulation
No Intervention: No intervention



Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: Four weeks ]
  2. NYHA functional class [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Brain natriuretic peptide (BNP) [ Time Frame: Four weeks ]
  2. 6-minutes walking test [ Time Frame: Four weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837771


Contacts
Layout table for location contacts
Contact: Paul Erne, MD ++41 41 205 5208 paul.erne@luks.ch

Locations
Layout table for location information
Switzerland
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, CH-6000
Contact: Paul Erne, MD    ++41 41 205 5208    paul.erne@luks.ch   
Sub-Investigator: Andreas W Schoenenberger, MD         
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Layout table for investigator information
Principal Investigator: Paul Erne, MD Luzerner Kantonsspital

Layout table for additonal information
Responsible Party: Prof. Paul Erne, Head of Department of Cardiology, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT01837771    
Other Study ID Numbers: 13008
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases