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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
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Charles University, Czech Republic

Tracking Information
First Submitted Date June 5, 2008
First Posted Date June 9, 2008
Last Update Posted Date April 28, 2009
Study Start Date January 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
frozen serum for collagen metabolism detection
Sampling Method Non-Probability Sample
Study Population patients with aortic stenosis and left ventricular hypertrophy
Condition Aortic Stenosis
Intervention Not Provided
Study Groups/Cohorts
  • I, observation
    patients with aortic stenosis
  • II, observation
    patients with aortic stenosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June 6, 2008)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number NCT00693797
Other Study ID Numbers NR/9022-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.Zeman, Faculty hospital, Královské Vinohrady, Prague , Czech Republic
Study Sponsor Charles University, Czech Republic
Collaborators Ministry of Health, Czech Republic
Investigators
Principal Investigator: Jirmář Radovan, M.D., Ph.D. Faculty hospital Královské Vinohrady
PRS Account Charles University, Czech Republic
Verification Date April 2009