- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00560339
Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients? (IMPEDE-HF)
November 15, 2007 updated by: Southern New Jersey Cardiac Specialists
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Glendale, California, United States
- Recruiting
- Glendale Memorial Hospital and Health Center
-
Contact:
- Jimmy Grape
- Email: Jimmy.Grape@CHW.edu
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-
New Jersey
-
Voorhees, New Jersey, United States
- Recruiting
- Southern New Jersey Cardiac Specialists
-
Contact:
- Mary Friedman
- Email: mfriedman@ccsheart.com
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-
New York
-
Roslyn, New York, United States
- Recruiting
- St. Francis Hospital
-
Contact:
- Rebecca Seeman
- Email: Rebecca.Seeman@chsli.org
-
-
North Carolina
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Charlotte, North Carolina, United States
- Recruiting
- Carolinas Healthcare System/The Sanger Clinic
-
Contact:
- Connie Dellinger
- Email: connie.dellinger@carolinashealthcare.org
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-
Tennessee
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Nashville, Tennessee, United States
- Recruiting
- Mid State Cardiology Associates
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Contact:
- Janice Sensing
- Email: janice.sensing@midstatecardiology.com
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-
Wisconsin
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Milwaukee, Wisconsin, United States
- Not yet recruiting
- Medical College of Wisconsin /Froedtert Hospital
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Contact:
- Susan Mauermann
- Email: smauerma@mcw.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John Andriulli, DO, Southern New Jersey Cardiac Specialists
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion
December 7, 2022
Study Completion (Anticipated)
January 1, 2009
Study Registration Dates
First Submitted
November 15, 2007
First Submitted That Met QC Criteria
November 15, 2007
First Posted (Estimate)
November 19, 2007
Study Record Updates
Last Update Posted (Estimate)
November 19, 2007
Last Update Submitted That Met QC Criteria
November 15, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20051601
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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