Clinical trial NCT00560339: Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
Official title: Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Implantable Defibrillators
Intrathoracic Impedance
Lead sponsor: Southern New Jersey Cardiac Specialists
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Health Center
state: California
city: Voorhees
country: United States
facility: Southern New Jersey Cardiac Specialists
state: New Jersey
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System/The Sanger Clinic
state: North Carolina
city: Nashville
country: United States
facility: Mid State Cardiology Associates
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Southern New Jersey Cardiac Specialists
name: John Andriulli, DO
role: PRINCIPAL_INVESTIGATOR
References: