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

Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? (IMPEDE-HF)

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: NCT00560339
Recruitment Status : Unknown
Verified November 2007 by Southern New Jersey Cardiac Specialists.
Recruitment status was:  Recruiting
First Posted : November 19, 2007
Last Update Posted : November 19, 2007
Sponsor:
Collaborator:
Medtronic
Information provided by:
Southern New Jersey Cardiac Specialists

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether there is a relationship between serial B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in symptomatic and asymptomatic heart failure patients over a 1-year period. Furthermore, this study will establish whether implantable device measured intrathoracic impedance trends with the distance walked on a six-minute hall walk (6MHW), an exercise-based acute measure that has also been associated with heart failure clinical status.

Condition or disease
Congestive Heart Failure

Detailed Description:
This is a prospective non-randomized longitudinal study. One hundred subjects will participate in 6 monthly and 3 bi-monthly serial assessments of plasma-based BNP, implantable device measured intrathoracic impedance, and clinical evaluation of heart failure status. Each patient will be enrolled in the study for a period of 12 months.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
Study Start Date : September 2005
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
Criteria

Inclusion Criteria:

  • Baseline BNP > 80 pg/ml
  • Meets current guidelines for ICD implantation with or without CRT
  • Receiving a Medtronic InSync Sentry, Concerto, Virtuoso, or subsequently approved Medtronic ICD with the OptiVol feature.
  • Walk < 450 meters during 6 minute hall walk test

Exclusion Criteria:

  • Less than 18 years of age
  • Life expectancy < 6 months
  • History of non-compliance with clinic visits or study-related tasks which may decrease chance of completing of the study
  • Physical disability which limits exercise
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00560339


Locations
Layout table for location information
United States, California
Glendale Memorial Hospital and Health Center Recruiting
Glendale, California, United States
Contact: Jimmy Grape       Jimmy.Grape@CHW.edu   
United States, New Jersey
Southern New Jersey Cardiac Specialists Recruiting
Voorhees, New Jersey, United States
Contact: Mary Friedman       mfriedman@ccsheart.com   
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States
Contact: Rebecca Seeman       Rebecca.Seeman@chsli.org   
United States, North Carolina
Carolinas Healthcare System/The Sanger Clinic Recruiting
Charlotte, North Carolina, United States
Contact: Connie Dellinger       connie.dellinger@carolinashealthcare.org   
United States, Tennessee
Mid State Cardiology Associates Recruiting
Nashville, Tennessee, United States
Contact: Janice Sensing       janice.sensing@midstatecardiology.com   
United States, Wisconsin
Medical College of Wisconsin /Froedtert Hospital Not yet recruiting
Milwaukee, Wisconsin, United States
Contact: Susan Mauermann       smauerma@mcw.edu   
Sponsors and Collaborators
Southern New Jersey Cardiac Specialists
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: John Andriulli, DO Southern New Jersey Cardiac Specialists
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00560339    
Other Study ID Numbers: 20051601
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: November 2007
Keywords provided by Southern New Jersey Cardiac Specialists:
Congestive Heart Failure
Implantable Defibrillators
Intrathoracic Impedance
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases