Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure

Completed

• Conditions: Coronary Artery Disease; Heart Failure; Cardiomyopathies

• Registration Number: NCT01210157
• Lead Sponsor: Heidelberg University

Brief Summary

The purpose of this study is to determine whether galectin-3 binding protein plasma levels can predict adverse cardiovascular events in patients with coronary artery disease and/or heart failure.

Detailed Description

Chronic heart failure represents an important cause of disease burden in Western countries. Heart failure can be either caused by vascular disease (i.e. cardiomypathy (CMP) due to coronary artery disease ("ischemic/ICMP")) or by myocardial conditions (i.e. dilated cardiomyopathies (DCMP) resulting from other causes like familial disposition, drug toxicity, etc.). Gold standard for the diagnosis of CMPs is the coronary angiography in conjunction with left ventricular angiography and myocardial biopsy, non-invasive markers include C-reactive protein (CRP) for ICMP and brain natriuretic protein (BNP) for DCMP. We have previously identified G3BP to be overexpressed in foam cells and plasma-derived microparticles, both potentially important in formation of atherosclerotic plaque. Galectin-3 binding protein (G3BP) is a secreted protein that is involved in cell adhesion and immune activation. The purpose of the current study is to test, whether G3BP plasma levels (a) are able to non-invasively differentiate causes of CMP and (b) are a suitable means for future risk assessment in CMP patients.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-09
• Study Completion: 2010-08
• Study First Submitted: 2010-08-11
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-27
• Last Update Submitted: 2010-09-27
• Study First Posted: 2010-09-28
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• impaired ventricular function

Exclusion Criteria

• neoplastic disease
• infections with hepatitis C or HIV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death from cardiac causes	up to five years

Secondary Outcome Measures

Name	Time	Method
diagnosis of coronary artery disease (CAD)	up to five years
non-fatal myocardial infarction or cerebrovascular accident	up to five years
diagnosis of cardiomypathy (CMP)	up to five years
assessment of disease stage (CAD-1-3, NYHA I-IV)	up to five years
revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))	up to five years
rehospitalization	up to five years
implantation of ICD/biventricular pacemaker	up to five years
correlation with routine lab values	up to five years
heart transplantation	up to five years
correlation with patient history	up to five years
correlation with physical examination	up to five years
correlation with ECG	up to five years
correlation with echocardiography	up to five years
correlation with cardiac MRI	up to five years
correlation with cardiac CT	up to five years
correlation with chest X-ray	up to five years

Trial Locations

Locations (1)

University of Heidelberg, Dept. of Cardiology; 🇩🇪 Heidelberg, Germany