Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

This study has been withdrawn prior to enrollment.
(resources not available)
Sponsor:
Information provided by (Responsible Party):
Uma Srivatsa, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00580255
First received: December 20, 2007
Last updated: January 7, 2013
Last verified: January 2013
  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

Study Type: Observational
Study Design: 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?

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

Biospecimen Retention:   Samples Without DNA

Teaspoon of blood drawn for testing of BNP levels.


Enrollment: 0
Study Start Date: October 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
U C Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Uma Srivatsa, MD U C Davis Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Uma Srivatsa, MD, Assistant Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00580255     History of Changes
Other Study ID Numbers: 200614766
Study First Received: December 20, 2007
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014