NCT00560339

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 19, 2007

Status Verified

November 1, 2007

First QC Date

November 15, 2007

Last Update Submit

November 15, 2007

Conditions

Keywords

Congestive Heart FailureImplantable DefibrillatorsIntrathoracic Impedance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy (CRT).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Glendale Memorial Hospital and Health Center

Glendale, California, United States

RECRUITING

Southern New Jersey Cardiac Specialists

Voorhees Township, New Jersey, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, United States

RECRUITING

Carolinas Healthcare System/The Sanger Clinic

Charlotte, North Carolina, United States

RECRUITING

Mid State Cardiology Associates

Nashville, Tennessee, United States

RECRUITING

Medical College of Wisconsin /Froedtert Hospital

Milwaukee, Wisconsin, United States

NOT YET RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John Andriulli, DO

    Southern New Jersey Cardiac Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 19, 2007

Study Start

September 1, 2005

Study Completion

January 1, 2009

Last Updated

November 19, 2007

Record last verified: 2007-11

Locations