Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

Charles University, Czech Republic

Status: Completed

Conditions: Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT00693797

NR/9022-3

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

50 participants in 2 patient groups

I, observation

Description:

patients with aortic stenosis

II, observation

Description:

patients with aortic stenosis