Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? - Full Text View

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

This study is currently recruiting participants.

Verified by Southern New Jersey Cardiac Specialists, November 2007

Sponsors and Collaborators:	Southern New Jersey Cardiac Specialists Medtronic
Information provided by:	Southern New Jersey Cardiac Specialists
ClinicalTrials.gov Identifier:	NCT00560339

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Keywords provided by Southern New Jersey Cardiac Specialists:

Congestive Heart Failure
Implantable Defibrillators
Intrathoracic Impedance

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009