Status:
COMPLETED
Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 dias...
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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT00419965
Start Date
October 1 2006
End Date
May 1 2010
Last Update
August 20 2010
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107