Comparison Study of BNP and Thoracic Impedance Measurements on 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...
Brief Summary
Official Title: “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.
- Study Type: Observational
- Study Design: Observational Model: Cohort, Time Perspective: Prospective
- Study Primary Completion Date: October 2009
Detailed Clinical Trial 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.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University of California, Davis Other
Overall Clinical Trial Officials and Contacts
Uma Drivatsa, MD Principal Investigator U C Davis Medical Center
Overall Contact: Melissa Mangum, BS 916-734-7199 melissa.mangum@ucdmc.ucdavis.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580255
Study ID Number: 200614766
ClinicalTrials.gov Identifier: NCT00580255
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00580255
