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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 8, 2007 | ||||||||
| Last Updated Date | January 22, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00419965 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Measuring G Protein-Coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure | ||||||||
| Official Title ICMJE | Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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). |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Estimated Completion Date | February 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00419965 | ||||||||
| Responsible Party | Walter J. Koch PhD (PI), Thomas Jefferson University Office of Research Administration | ||||||||
| Study ID Numbers ICMJE | 06C.358 | ||||||||
| Study Sponsor ICMJE | Thomas Jefferson University | ||||||||
| Collaborators ICMJE | Johnson & Johnson | ||||||||
| Investigators ICMJE |
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| Information Provided By | Thomas Jefferson University | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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