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.

Study Timeline

• Study Start: 2005-09
• Status Verified: 2007-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Last Update Submitted: 2007-11-15
• Study First Posted: 2007-11-19
• Last Update Posted: 2007-11-19
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Southern New Jersey Cardiac Specialists; 🇺🇸 Voorhees, New Jersey, United States

Medical College of Wisconsin /Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States

Glendale Memorial Hospital and Health Center; 🇺🇸 Glendale, California, United States

Carolinas Healthcare System/The Sanger Clinic; 🇺🇸 Charlotte, North Carolina, United States

Mid State Cardiology Associates; 🇺🇸 Nashville, Tennessee, United States