Recruiting

Observational Study

Sponsor:

Southern New Jersey Cardiac Specialists

Code:

NCT00560339

Conditions

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Congestive Heart Failure

Study ID

NCT00560339

Start date

Sep, 2005

Status verified date

Nov, 2007

Completion date

Jan, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Locations

Glendale Memorial Hospital and Health Center

Recruiting

Glendale, California, United States

Contacts

Jimmy Grape

Jimmy.Grape@CHW.edu

Southern New Jersey Cardiac Specialists

Recruiting

Voorhees, New Jersey, United States

Contacts

Mary Friedman

mfriedman@ccsheart.com

St. Francis Hospital

Recruiting

Roslyn, New York, United States

Contacts

Rebecca Seeman

Rebecca.Seeman@chsli.org

Carolinas Healthcare System/The Sanger Clinic

Recruiting

Charlotte, North Carolina, United States

Contacts

Connie Dellinger

connie.dellinger@carolinashealthcare.org

Mid State Cardiology Associates

Recruiting

Nashville, Tennessee, United States

Contacts

Janice Sensing

janice.sensing@midstatecardiology.com

More Information

Sponsor

Southern New Jersey Cardiac Specialists

Last update posted

Nov 19, 2007

Last verified

Nov, 2007

Keywords

  • Congestive Heart Failure
  • Implantable Defibrillators
  • Intrathoracic Impedance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern New Jersey Cardiac Specialists on 2007-11-19.