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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

Study Description
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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.

Condition or disease
Aortic Stenosis

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Groups and Cohorts
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Group/Cohort
I, observation
patients with aortic stenosis
II, observation
patients with aortic stenosis


Outcome Measures
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Primary Outcome Measures :
  1. 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
frozen serum for collagen metabolism detection

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with aortic stenosis and left ventricular hypertrophy
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Czech Republic
Faculty hospital Královské Vinohrady
Prague, Czech Republic, 100 34
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic
Investigators
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Principal Investigator: Jirmář Radovan, M.D., Ph.D. Faculty hospital Královské Vinohrady
More Information
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Responsible Party: M.Zeman, Faculty hospital, Královské Vinohrady, Prague , Czech Republic
ClinicalTrials.gov Identifier: NCT00693797    
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:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction