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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Southern New Jersey Cardiac Specialists.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by:
Southern New Jersey Cardiac Specialists
ClinicalTrials.gov Identifier:
NCT00560339
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

Resource links provided by NLM:


Further study details as provided by Southern New Jersey Cardiac Specialists:

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: January 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560339

Locations
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
Principal Investigator: John Andriulli, DO Southern New Jersey Cardiac Specialists
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00560339     History of Changes
Other Study ID Numbers: 20051601
Study First Received: November 15, 2007
Last Updated: November 15, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Southern New Jersey Cardiac Specialists:
Congestive Heart Failure
Implantable Defibrillators
Intrathoracic Impedance

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014