Congestive Heart FailureIMPEDE-HFNCT00560339
Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
An observational study of Congestive Heart Failure, run by Southern New Jersey Cardiac Specialists at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2005to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Carolinas Healthcare System/The Sanger Clinic
Charlotte, North Carolina
Connie Dellinger, connie.dellinger@carolinashealthcare.org
- Recruiting
Glendale Memorial Hospital and Health Center
Glendale, California
Jimmy Grape, Jimmy.Grape@CHW.edu
- Not yet recruiting
Medical College of Wisconsin /Froedtert Hospital
Milwaukee, Wisconsin
Susan Mauermann, smauerma@mcw.edu
- Recruiting
Mid State Cardiology Associates
Nashville, Tennessee
Janice Sensing, janice.sensing@midstatecardiology.com
- Recruiting
St. Francis Hospital
Roslyn, New York
Rebecca Seeman, Rebecca.Seeman@chsli.org
- Recruiting
Southern New Jersey Cardiac Specialists
Voorhees Township, New Jersey
Mary Friedman, mfriedman@ccsheart.com
About this study
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Implantable Defibrillators, Intrathoracic Impedance
- Medical subject headings
- Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startSep 2005
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern New Jersey Cardiac Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- John Andriulli, DO, Principal investigator, Southern New Jersey Cardiac Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560339
- Sponsor's protocol ID
- 20051601
- Acronym
- IMPEDE-HF
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 19 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Behnes M, Schmidberger M, Mashayekhi K, Vadala G, Moroni A, Guiterrez-Chico JL, Ayoub M, Christiansen EH, Pyxaras S, Bufe A, Krotz F, Schmitt A, Lau F, Reinhardt M, Forner J, Dudda J, Abel N, Hoepfner MK, Aubel C, Abumayyaleh M, Weidner K, Akin I, Schupp T. Coronary Chronic Total Occlusions Affect Long-Term Prognosis in Heart Failure With Mildly Reduced Ejection Fraction. J Am Heart Assoc. 2025 Sep 2;14(17):e042368. doi: 10.1161/JAHA.125.042368. Epub 2025 Aug 22.
PubMed 40847486
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?
- ClinicalTrials.gov ID
- NCT00560339
- Acronym / sponsor ID
- IMPEDE-HF / 20051601
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Implantable Defibrillators, Intrathoracic Impedance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southern New Jersey Cardiac SpecialistsUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2005
- Study completion
- Jan 2009 (estimated)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2007.
- Derived from this study: PubMed 40847486Behnes M, Schmidberger M, Mashayekhi K, Vadala G, Moroni A, Guiterrez-Chico JL, Ayoub M, Christiansen EH, Pyxaras S, Bufe A, Krotz F, Schmitt A, Lau F, Reinhardt M, Forner J, Dudda J, Abel N, Hoepfner MK, Aubel C, Abumayyaleh M, Weidner K, Akin I, Schupp T. Coronary Chronic Total Occlusions Affect Long-Term Prognosis in Heart Failure With Mildly Reduced Ejection Fraction. J Am Heart Assoc. 2025 Sep 2;14(17):e042368. doi: 10.1161/JAHA.125.042368. Epub 2025 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Andriulli, DO principal investigator
Southern New Jersey Cardiac Specialists
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Southern New Jersey Cardiac Specialists at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2007.