Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias

NCT ID: NCT00580255

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2006-11-30

Brief 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.

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.

Conditions

Heart Failure; Arrhythmias

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uma Srivatsa, MD

Role: PRINCIPAL_INVESTIGATOR

U C Davis Medical Center

Locations

U C Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

200614766

Identifier Type: -

Identifier Source: org_study_id