Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00693797
First received: June 5, 2008
Last updated: April 27, 2009
Last verified: April 2009

June 5, 2008
April 27, 2009
January 2006
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00693797 on ClinicalTrials.gov Archive Site
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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.

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

frozen serum for collagen metabolism detection

Non-Probability Sample

patients with aortic stenosis and left ventricular hypertrophy

Aortic Stenosis
Not Provided
  • I, observation
    patients with aortic stenosis
  • II, observation
    patients with aortic stenosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2009
December 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00693797
NR/9022-3
No
M.Zeman, Faculty hospital, Královské Vinohrady, Prague , Czech Republic
Charles University, Czech Republic
Ministry of Health, Czech Republic
Principal Investigator: Jirmář Radovan, M.D., Ph.D. Faculty hospital Královské Vinohrady
Charles University, Czech Republic
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP