NCT00693797

Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

As there are no clinical data in cardiology about the relationship between metabolism collagen changes and their clinical significance, the investigators will check the hypothesis that collagen metabolism changes, detected by biochemical markers for collagen metabolism, could predict the left ventricle remodelling and prognosis in patient with clinically significant pressure overloaded left ventricle.

Detailed description

Clinical assessment and endpoints: 1ST day (the day of entering the hospital or the day of the first contact): Informed consent (see below), clinical examination, ECG, complete echocardiography evaluating the function of the left ventricle (EF) and the presence and the significance of valvular disease, basic laboratory tests incl. CKMB, troponin I, taking of blood samples (5 ml) for the detection of collagen metabolism markers serum level, X-ray of chest, 2nd-3rd day: clinical examination, ECG, basic laboratory tests incl.CKMB, troponin I (only group I) 4th day: clinical check up, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level (only group I) 30th day: clinical examination l, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level, 24 hrs ECG monitoring (holter) 6 months: clinical examination, ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism markers serum level, holter monitoring 1 year: history, clinical examination Primary endpoint: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up. Secondary endpoints: rehospitalisation for cardiovascular reason, clinically significant arrhythmias, correlations between left ventricle parameters evaluated by echocardiography and collagen metabolism changes evaluated by serum markers

Conditions

• Aortic Stenosis

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-06-09
• Last updated: 2009-04-28

Locations

1 site across 1 country: Czechia