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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560339

Locations
United States, California
Glendale Memorial Hospital and Health Center
Glendale, California, United States
United States, New Jersey
Southern New Jersey Cardiac Specialists
Voorhees, New Jersey, United States
United States, New York
St. Francis Hospital
Roslyn, New York, United States
United States, North Carolina
Carolinas Healthcare System/The Sanger Clinic
Charlotte, North Carolina, United States
United States, Tennessee
Mid State Cardiology Associates
Nashville, Tennessee, United States
United States, Wisconsin
Medical College of Wisconsin /Froedtert Hospital
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Southern New Jersey Cardiac Specialists
Medtronic
Investigators
Principal Investigator: John Andriulli, DO Southern New Jersey Cardiac Specialists
  More Information

ClinicalTrials.gov Identifier: NCT00560339     History of Changes
Other Study ID Numbers: 20051601 
Study First Received: November 15, 2007
Last Updated: November 15, 2007

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 January 19, 2017