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

Completed

• Conditions: Heart Failure

• Registration Number: NCT00419965
• Lead Sponsor: Thomas Jefferson University

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.

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).

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-18
• Last Update Posted: 2010-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States