Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle
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ClinicalTrials.gov Identifier: NCT00693797 |
Recruitment Status
:
Completed
First Posted
: June 9, 2008
Last Update Posted
: April 28, 2009
|
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Condition or disease |
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Aortic Stenosis |
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
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle. |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |

Group/Cohort |
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I, observation
patients with aortic stenosis
|
II, observation
patients with aortic stenosis
|
- Primary outcome: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up. [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- isolated severe aortic stenosis (index aortic valve area less than 0,5 cm2/m2 or mean transaortic pressure gradient more than 40 mm Hg, assessed by echocardiography) and left ventricular hypertrophy (see above)
- signed informed consent
Exclusion Criteria:
- presence of more than mild aortic regurgitation or other significant valvular lesion
- impossibility to obtain echocardiographic tracing of good quality
- all other diseases, which significantly influence collagen metabolism (renal failure, insulin dependent diabetes mellitus, bone diseases, hepatic failure)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693797
Czech Republic | |
Faculty hospital Královské Vinohrady | |
Prague, Czech Republic, 100 34 |
Principal Investigator: | Jirmář Radovan, M.D., Ph.D. | Faculty hospital Královské Vinohrady |
Responsible Party: | M.Zeman, Faculty hospital, Královské Vinohrady, Prague , Czech Republic |
ClinicalTrials.gov Identifier: | NCT00693797 History of Changes |
Other Study ID Numbers: |
NR/9022-3 |
First Posted: | June 9, 2008 Key Record Dates |
Last Update Posted: | April 28, 2009 |
Last Verified: | April 2009 |
Keywords provided by Charles University, Czech Republic:
ventricular hypertrophy collagen aortic stenosis |
Additional relevant MeSH terms:
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |