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

NCT ID: NCT00560339

Last Updated: 2007-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-01-31

Brief Summary

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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

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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

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Congestive Heart Failure

Keywords

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Congestive Heart Failure Implantable Defibrillators Intrathoracic Impedance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Southern New Jersey Cardiac Specialists

OTHER

Sponsor Role lead

Principal Investigators

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John Andriulli, DO

Role: PRINCIPAL_INVESTIGATOR

Southern New Jersey Cardiac Specialists

Locations

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Glendale Memorial Hospital and Health Center

Glendale, California, United States

Site Status RECRUITING

Southern New Jersey Cardiac Specialists

Voorhees Township, New Jersey, United States

Site Status RECRUITING

St. Francis Hospital

Roslyn, New York, United States

Site Status RECRUITING

Carolinas Healthcare System/The Sanger Clinic

Charlotte, North Carolina, United States

Site Status RECRUITING

Mid State Cardiology Associates

Nashville, Tennessee, United States

Site Status RECRUITING

Medical College of Wisconsin /Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Facility Contacts

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Jimmy Grape

Role: primary

Mary Friedman

Role: primary

Rebecca Seeman

Role: primary

Connie Dellinger

Role: primary

Janice Sensing

Role: primary

Susan Mauermann

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40847486 (View on PubMed)

Other Identifiers

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20051601

Identifier Type: -

Identifier Source: org_study_id