Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00693797

First Posted: June 9, 2008

Last Update Posted: April 28, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Ministry of Health, Czech Republic

Information provided by:

Charles University, Czech Republic

Purpose

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
Aortic Stenosis


Study Type:	Observational
Study Design:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: supravalvular aortic stenosis

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:

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


Estimated Enrollment:	50
Study Start Date:	January 2006
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
I, observation patients with aortic stenosis
II, observation patients with 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

Eligibility

Information from the National Library of Medicine

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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

Study Population

patients with aortic stenosis and left ventricular hypertrophy

Criteria

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)

Contacts and Locations

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


Czech Republic
Faculty hospital Královské Vinohrady
Prague, Czech Republic, 100 34

Sponsors and Collaborators

Charles University, Czech Republic

Ministry of Health, Czech Republic

Investigators


Principal Investigator:	Jirmář Radovan, M.D., Ph.D.	Faculty hospital Královské Vinohrady

More Information


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 Submitted:	June 5, 2008
First Posted:	June 9, 2008
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

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