Brief Title
Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle
Official Title
Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle.
Brief 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
Study Type
Observational
Primary Outcome
Primary outcome: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up.
Condition
Aortic Stenosis
Study Arms / Comparison Groups
I, observation
Description: patients with aortic stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
50
Start Date
January 2006
Completion Date
January 2009
Primary Completion Date
December 2008
Eligibility Criteria
Inclusion Criteria: 1. 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) 2. signed informed consent Exclusion Criteria: 1. presence of more than mild aortic regurgitation or other significant valvular lesion 2. impossibility to obtain echocardiographic tracing of good quality 3. all other diseases, which significantly influence collagen metabolism (renal failure, insulin dependent diabetes mellitus, bone diseases, hepatic failure)
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jirmář Radovan, M.D., Ph.D., ,
Location Countries
Czech Republic
Location Countries
Czech Republic
Administrative Informations
NCT ID
NCT00693797
Organization ID
NR/9022-3
Study Sponsor
Charles University, Czech Republic
Collaborators
Ministry of Health, Czech Republic
Study Sponsor
Jirmář Radovan, M.D., Ph.D., Principal Investigator, Faculty hospital Královské Vinohrady
Verification Date
April 2009