Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? (IMPEDE-HF)
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ClinicalTrials.gov Identifier: NCT00560339
Recruitment Status : Unknown
Verified November 2007 by Southern New Jersey Cardiac Specialists. Recruitment status was: Recruiting
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
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
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
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