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Completed

NCT Number: NCT00419965

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 9, 2007
Registry last updated
Aug 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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