Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure |
Frozen serum/plasma - coded samples
| Enrollment: | 582 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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:
- Normal Controls: Individuals without HF, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity;
- Group I: Symptomatic Subjects with Reduced LV Function, HF symptoms, EF ≤ 40%.
- Group II: Asymptomatic Patients with LV dysfunction, no HF symptoms (NYHA class I and ATS score 0 or 1, EF ≤ 40%.
- Group III: Symptomatic Subjects with Preserved LV Function, HF symptoms, EF ≥ 50%, and diastolic dysfunction.
- Group IV: Asymptomatic High Risk Subjects - Individuals with normal heart function, no HF symptoms (NYHA class I and ATS score 0 or 1), Preserved LV function (EF ≥ 50%), no diastolic dysfunction. Also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age >70 years
Exclusion Criteria
- Pregnancy
- Not providing consent
- Inability to provide consent
- Participation in a clinical study involving an experimental therapy.
Contacts and Locations| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Walter J. Koch, PhD | Thomas Jefferson University |
More Information
No publications provided
| Responsible Party: | Walter J. Koch PhD (PI), Thomas Jefferson University Office of Research Administration |
| ClinicalTrials.gov Identifier: | NCT00419965 History of Changes |
| Other Study ID Numbers: | 06C.358 |
| Study First Received: | January 8, 2007 |
| Last Updated: | August 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013