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Sponsors and Collaborators: |
Charles University, Czech Republic Ministry of Health, Czech Republic |
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Information provided by: | Charles University, Czech Republic |
ClinicalTrials.gov Identifier: | NCT00693797 |
As there are no clinical data in cardiology about the relationship between metabolism collagen changes and their clinical significance, we should like to check 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.
Condition |
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Aortic Stenosis |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle. |
frozen serum for collagen metabolism detection
Estimated Enrollment: | 50 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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I, II, observation:
patients with aortic stenosis
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2 |
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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
patients with aortic stenosis and left ventricular hypertrophy
Inclusion Criteria:
Exclusion Criteria:
Contact: Radovan Jirmář, M.D., Ph.D. | +420267162899 | jirmar@fnkv.cz |
Czech Republic | |
Faculty hospital Královské Vinohrady | Recruiting |
Prague, Czech Republic, 100 34 | |
Contact: Radovan Jirmář, M.D., Ph.D. +420267162899 jirmar@fnkv.cz | |
Principal Investigator: Radovan Jirmář, M.D., Ph.D. |
Principal Investigator: | Jirmář Radovan, M.D., Ph.D. | Faculty hospital Královské Vinohrady |
Responsible Party: | Faculty hospital, Královské Vinohrady, Prague , Czech Republic ( M.Zeman ) |
Study ID Numbers: | NR/9022-3 |
Study First Received: | June 5, 2008 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00693797 |
Health Authority: | Czech Republic: Ethics Committee |
ventricular hypertrophy,collagen, aortic stenosis |
Hypertrophy Heart Diseases Constriction, Pathologic |
Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |