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Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

This study is currently recruiting participants.
Verified by University of California, Davis, June 2008

Sponsored by: University of California, Davis
Information provided by: University of California, Davis
ClinicalTrials.gov Identifier: NCT00580255
  Purpose

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
Heart Failure
Arrhythmias

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Arrhythmia    Heart Failure   

ChemIDplus related topics:   Nesiritide   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Does Elevated Brain Natriuretic Peptide (BNP) Reflect Changes in Thoracic Impedance Levels and Affect Occurrence of Atrial and Ventricular Arrhythmias?

Further study details as provided by University of California, Davis:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Teaspoon of blood drawn for testing of BNP levels.


Estimated Enrollment:   25
Study Start Date:   October 2006
Estimated Study Completion Date:   October 2009
Estimated Primary Completion Date:   October 2009 (Final data collection date for primary outcome measure)

Detailed 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.
  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Potential candidates with criteria for implantable cardiac resynchronization therapy who have or will undergo implantation of a Medtronic CRT-D device with thoracic impedance measurement capabilities, will be eligible to enter the study if they meet all of the inclusion criteria and none of the exclusion criteria. Patients will be enrolled in the study either at the time of device implantation or if they have already undergone device implantation will be enrolled at next routine outpatient clinic visit.


Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580255

Contacts
Contact: Melissa Mangum, BS     916-734-7199     melissa.mangum@ucdmc.ucdavis.edu    
Contact: Uma Srivatsa, MD     916-734-3764     uma.srivatsa@ucdmc.ucdavis.edu    

Locations
United States, California
U C Davis Medical Center     Recruiting
      Sacramento, California, United States, 95817

Sponsors and Collaborators
University of California, Davis

Investigators
Principal Investigator:     Uma Drivatsa, MD     U C Davis Medical Center    
  More Information

Clinical Trials at UC Davis Medical Center  This link exits the ClinicalTrials.gov site
 

Responsible Party:   U C Davis Medical Center ( Uma Srivatsa, MD )
Study ID Numbers:   200614766
First Received:   December 20, 2007
Last Updated:   June 4, 2008
ClinicalTrials.gov Identifier:   NCT00580255
Health Authority:   United States: Institutional Review Board

Keywords provided by University of California, Davis:
CHF  
CRT  
Atrial Arrhythmias  
Ventricular Arrhythmias
BioZ
Optivol

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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