Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle - Full Text View

Sponsors and Collaborators:	Charles University, Czech Republic Ministry of Health, Czech Republic
Information provided by:	Charles University, Czech Republic
ClinicalTrials.gov Identifier:	NCT00693797

Purpose

As there are no clinical data in cardiology about the relationship between metabolism collagen changes and their clinical significance, we should like to check 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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle.

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

frozen serum for collagen metabolism detection

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

Groups/Cohorts
I, II, observation: patients with aortic stenosis
2

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693797

Contacts

Contact: Radovan Jirmář, M.D., Ph.D.

+420267162899

jirmar@fnkv.cz

Locations

Czech Republic
Faculty hospital Královské Vinohrady	Recruiting
Prague, Czech Republic, 100 34
Contact: Radovan Jirmář, M.D., Ph.D. +420267162899 jirmar@fnkv.cz
Principal Investigator: Radovan Jirmář, M.D., Ph.D.

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:	Faculty hospital, Královské Vinohrady, Prague , Czech Republic ( M.Zeman )
Study ID Numbers:	NR/9022-3
Study First Received:	June 5, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00693797
Health Authority:	Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:

ventricular hypertrophy,collagen, aortic stenosis

Study placed in the following topic categories:

Hypertrophy
Heart Diseases
Constriction, Pathologic

Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on January 16, 2009