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Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419965
First Posted: January 9, 2007
Last Update Posted: August 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by:
Thomas Jefferson University
  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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Biospecimen Retention:   Samples With DNA
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)
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419965


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Johnson & Johnson
Investigators
Principal Investigator: Walter J. Koch, PhD Thomas Jefferson University
  More Information

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
First Submitted: January 8, 2007
First Posted: January 9, 2007
Last Update Posted: August 20, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases