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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 is currently recruiting participants.
Verified by Thomas Jefferson University, June 2008

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure

Further study details as provided by Thomas Jefferson University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Frozen serum/plasma - coded samples


Estimated Enrollment:   600
Study Start Date:   October 2006
Estimated Study Completion Date:   September 2008

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419965

Contacts
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    

Locations
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            

Sponsors and Collaborators
Thomas Jefferson University
Johnson & Johnson

Investigators
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

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2008




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