Comparison Study of BNP and Thoracic Impedance Measurements on Arrhythmias
This study has been withdrawn prior to enrollment.
(resources not available)
Sponsor:
University of California, Davis
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
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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? |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Biospecimen Retention: Samples Without DNA
Detailed Description:
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) |
The primary aim of this study:
- 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.
- 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
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:
|
Arrhythmias, Cardiac Heart Failure Heart Diseases Cardiovascular Diseases Pathologic Processes Natriuretic Peptide, Brain |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013