Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2005 |
| End Date: | January 2009 |
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.
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.
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.
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.
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
We found this trial at
6
sites
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