Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

Sponsor

University of California, Davis (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00580255

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is hypothesized that elevated BNP level correlate with an elevated thoracic impedance/fluid index as measured separately by CRT-D devices and external impedance cardiography. Ultimately, it is also hypothesized that both BNP and thoracic impedance/fluid index measurements are predictive of atrial and ventricular arrhythmias.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Arrhythmias

Detailed Description

The primary aim of this study:

To assess the correlation between elevated brain natriuretic peptide levels and elevated thoracic impedance/body fluid index as measured by selective biventricular resynchronization devices and an external impedance cardiography device.
Correlate impedance measurements and brain natriuretic levels with occurrence of atrial and ventricular arrhythmias as assessed by interrogation of biventricular devices.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Does Elevated Brain Natriuretic Peptide (BNP) Reflect Changes in Thoracic Impedance Levels and Affect Occurrence of Atrial and Ventricular Arrhythmias?

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female between 18 to 85 years of age.
All patients with biventricular implantable cardio-defibrillators(manufacturer: Medtronic/ model: InSync 7299/7297 or newer).
LVEF <35%
NYHA III/IV
QRS >120 msec
Pt willing and able to sign informed consent.
Conventional heart failure therapy
Clinically stable for six months.

Exclusion Criteria:

age less than 18 years of age
age greater than 85 years of age
Creatinine > 2.5 mg/dl.
End stage liver disease complicated by ascites as determined by electronic medical record review.
women who are pregnant, lactating, or plan to become pregnant during the course of the study.
Patients who are heart transplant candidates with expected transplantation within the next six months.
Life expectancy due to non-cardiac cause less than one year.
Anticipated problem with compliance.
Critical valvular stenoses/insufficiencies.
Morbidly obese patients(>300 lbs.)
In patients whom impedance cardiography was not able to be performed because of inability to place sensors.
Planned or known need for revascularization procedures within three months.