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Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? (IMPEDE-HF)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Southern New Jersey Cardiac Specialists.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Southern New Jersey Cardiac Specialists
Collaborator:
Medtronic
Information provided by:
Southern New Jersey Cardiac Specialists
ClinicalTrials.gov Identifier:
NCT00560339
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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Purpose
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.
| Condition |
|---|
| Congestive Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? |
Resource links provided by NLM:
Further study details as provided by Southern New Jersey Cardiac Specialists:
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | January 2009 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00560339
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560339
Locations
| United States, California | |
| Glendale Memorial Hospital and Health Center | Recruiting |
| Glendale, California, United States | |
| Contact: Jimmy Grape Jimmy.Grape@CHW.edu | |
| United States, New Jersey | |
| Southern New Jersey Cardiac Specialists | Recruiting |
| Voorhees, New Jersey, United States | |
| Contact: Mary Friedman mfriedman@ccsheart.com | |
| United States, New York | |
| St. Francis Hospital | Recruiting |
| Roslyn, New York, United States | |
| Contact: Rebecca Seeman Rebecca.Seeman@chsli.org | |
| United States, North Carolina | |
| Carolinas Healthcare System/The Sanger Clinic | Recruiting |
| Charlotte, North Carolina, United States | |
| Contact: Connie Dellinger connie.dellinger@carolinashealthcare.org | |
| United States, Tennessee | |
| Mid State Cardiology Associates | Recruiting |
| Nashville, Tennessee, United States | |
| Contact: Janice Sensing janice.sensing@midstatecardiology.com | |
| United States, Wisconsin | |
| Medical College of Wisconsin /Froedtert Hospital | Not yet recruiting |
| Milwaukee, Wisconsin, United States | |
| Contact: Susan Mauermann smauerma@mcw.edu | |
Sponsors and Collaborators
Southern New Jersey Cardiac Specialists
Medtronic
Investigators
| Principal Investigator: | John Andriulli, DO | Southern New Jersey Cardiac Specialists |
More Information
| ClinicalTrials.gov Identifier: | NCT00560339 History of Changes |
| Other Study ID Numbers: |
20051601 |
| Study First Received: | November 15, 2007 |
| Last Updated: | November 15, 2007 |
Keywords provided by Southern New Jersey Cardiac Specialists:
|
Congestive Heart Failure Implantable Defibrillators Intrathoracic Impedance |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 20, 2017