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
  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:


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

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

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: June 5, 2008
Last Updated: April 27, 2009
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
ventricular hypertrophy
collagen
aortic stenosis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014