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| Sponsors and Collaborators: |
Thomas Jefferson University Johnson & Johnson |
| Information provided by: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00419965 |
Purpose
The primary objective of this study is to determine the utility of GRK2 to differentiate between normal patients and patient groups that differ by the presence/absence of HF symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring GRK2 levels.
| Condition |
|
Heart Failure |
| MedlinePlus related topics: | Heart Failure |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure |
Frozen serum/plasma - coded samples
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | September 2008 |
This study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. We will test blood cell samples for the levels of this molecule, called "G protein-coupled receptor kinase-2" (GRK2) using both the existing method of GRK2 quantification in the Koch laboratory and using a prototype enzyme immunoassay (EIA) method being developed by Johnson & Johnson, Ortho-Clinical Diagnostics (OCD).
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The study population subjects includes individuals in a range of age groups with a diagnosis of heart failure or at least one cardiovascular risk factor along with a subset of normal control subjects.
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations| Contact: Suzanne Adams, RN MPH | 215 955 8848 | suzanne.adams@jefferson.edu |
| Contact: David J. Whellan, MD MHS | 215 955 2636 | david.whellan@jefferson.edu |
| United States, Pennsylvania | |||||
| Thomas Jefferson University | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Sub-Investigator: Paul J. Mather, MD | |||||
| Sub-Investigator: Sharon Rubin, MD | |||||
| Sub-Investigator: David J. Whellan, MD MHS | |||||
| Thomas Jefferson University |
| Johnson & Johnson |
| Principal Investigator: | Walter J. Koch, PhD | Thomas Jefferson University |
More Information
| Responsible Party: | Thomas Jefferson University Office of Research Administration ( Walter J. Koch PhD (PI) ) |
| Study ID Numbers: | 06C.358 |
| First Received: | January 8, 2007 |
| Last Updated: | June 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00419965 |
| Health Authority: | United States: Institutional Review Board |
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