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Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias
This study is currently recruiting participants.
Study NCT00580255   Information provided by University of California, Davis
First Received: December 20, 2007   Last Updated: June 4, 2008   History of Changes

December 20, 2007
June 4, 2008
October 2006
October 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00580255 on ClinicalTrials.gov Archive Site
 
 
 
Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias
Does Elevated Brain Natriuretic Peptide (BNP) Reflect Changes in Thoracic Impedance Levels and Affect Occurrence of Atrial and Ventricular Arrhythmias?

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.

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.
 
Observational
Cohort, Prospective
  • Heart Failure
  • Arrhythmias
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
25
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Melissa Mangum, BS 916-734-7199 melissa.mangum@ucdmc.ucdavis.edu
Contact: Uma Srivatsa, MD 916-734-3764 uma.srivatsa@ucdmc.ucdavis.edu
United States
 
NCT00580255
Uma Srivatsa, MD, U C Davis Medical Center
200614766
University of California, Davis
 
Principal Investigator: Uma Drivatsa, MD U C Davis Medical Center
University of California, Davis
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP