Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

Southern New Jersey Cardiac Specialists100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Congestive Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Glendale Memorial Hospital and Health Center

Glendale, California, United States

RECRUITING

Southern New Jersey Cardiac Specialists

Voorhees Township, New Jersey, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, United States

Data from ClinicalTrials.gov

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