Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00580255
• Other study ID #: 200614766
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2007
• Last updated: June 19, 2017
• Start date: October 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2013
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary aim of this study:

1. 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.

2. Correlate impedance measurements and brain natriuretic levels with occurrence of atrial and ventricular arrhythmias as assessed by interrogation of biventricular devices.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias
• Heart Failure

Locations

Country	Name	City	State
United States	U C Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

External Links

•   Clinical Trials at UC Davis Medical Center