Congestive Heart Failure
Conditions
Keywords
Congestive Heart Failure, Implantable Defibrillators, Intrathoracic Impedance
Brief summary
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.
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.
Interventions
None listed
Sponsors
Medtronic
Southern New Jersey Cardiac Specialists
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed