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

Congestive Heart Failure Clinical Trial

— IMPEDE-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00560339
• Other study ID #: 20051601
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2007
• Last updated: November 15, 2007
• Start date: September 2005
• Est. completion date: January 2009

Study information

• Verified date: November 2007
• Source: Southern New Jersey Cardiac Specialists
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Carolinas Healthcare System/The Sanger Clinic	Charlotte	North Carolina
United States	Glendale Memorial Hospital and Health Center	Glendale	California
United States	Medical College of Wisconsin /Froedtert Hospital	Milwaukee	Wisconsin
United States	Mid State Cardiology Associates	Nashville	Tennessee
United States	St. Francis Hospital	Roslyn	New York
United States	Southern New Jersey Cardiac Specialists	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Southern New Jersey Cardiac Specialists	Medtronic

Country where clinical trial is conducted

United States,