Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT00560339
- Lead Sponsor
- Southern New Jersey Cardiac Specialists
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- Physical disability which limits exercise
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Glendale Memorial Hospital and Health Center
🇺🇸Glendale, California, United States
Southern New Jersey Cardiac Specialists
🇺🇸Voorhees, New Jersey, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Carolinas Healthcare System/The Sanger Clinic
🇺🇸Charlotte, North Carolina, United States
Mid State Cardiology Associates
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin /Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Glendale Memorial Hospital and Health Center🇺🇸Glendale, California, United StatesJimmy GrapeContactJimmy.Grape@CHW.edu