CClinicalTrials.gg
Sign In
Status unknownNCT00375336Updated Jan 1, 2009

Risk Factors Associated With Calcification of the Aortic Valve

An observational study in Aortic Stenosis and Aortic Sclerosis, sponsored by Charles University, Czech Republic. Status unknown at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-01.

Sponsored by Charles University, Czech Republic · Observational

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is

  • to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(CAD).
  • to determine whether there is relationship between calcium metabolism and calcific aortic valve disease associated with CAD.
Read the detailed description

Cardiovascular disease, mainly coronary artery disease, causes more than one half of deaths in the developed countries. Only recently, calcific aortic valve disease, was proved to belong to the family of atherosclerosis. It is associated with higher cardiovascular morbidity and mortality, the cause of which is not entirely clear. The link to significant coronary artery disease, probably, is of highest importance.

We compare groups of patients with coronary artery disease and calcific stenotic, sclerotic or intact aortic valve. The aim is to assess and compare their risk profile to verify our hypothesis that, within significant coronary artery disease, calcific aortic valve identifies a subgroup of patients with higher cardiovascular risk, assessed by endothelial dysfunction and the two year follow-up of cardiovascular events on optimally set treatment.

Further, we study the possible association of valvular calcification and calcium metabolism in patients with normal kidney function.

02

Conditions studied

  • Aortic Stenosis
  • Aortic Sclerosis

Browse trials for

Keywords

  • Aortic valve
  • Calcification
  • Endothelial dysfunction
  • Calcium metabolism
  • Coronary artery disease
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive patients admitted to hospital for evaluation due to common causes like dyspnea, chest pain, fatigue or syncope, who fulfilled the two inclusion criteria: 1/ angiographically significant CAD, and 2/ AS (mean transvalvular aortic gradient ≥30 mm Hg) or nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) or had normal aortic valve as diagnosed by echocardiography.

Inclusion criteria

  • significant stenosis (more than 50% diameter stenosis) of one or more coronary arteries
  • aortic sclerosis (group 1) or stenosis (AVA \< 1cm2/m2, or mean gradient ≥ 30 mmHg) (group 2) or normal aortic valve (group 3)

Exclusion criteria

Exclusion criteria:

  • Rheumatic heart disease (defined as aortic stenosis with commissural fusion + rheumatic mitral valve disease)
  • Status post aortic valve replacement
  • Congenital complex heart disease (except bicuspid aortic valve)
  • Moderate to severe aortic insufficiency (grade > 2/4)
  • Marfan syndrome
  • Infective endocarditis
  • Hypertrophic obstruction cardiomyopathy
  • Acute coronary syndrome within less than three months
  • Severe heart failure, NYHA class IV
  • Severe locomotion disability
  • Renal failure requiring dialysis
  • Significant systemic disease or other disease severely limiting the patient prognosis (e.g. known cancer, liver cirrhosis)
  • Primary hyperparathyroidism
  • Patient non-compliance
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    Patients with aortic stenosis (mean transvalvular aortic gradient ≥30 mm Hg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

  • 2

    Patients with nonobstructive aortic sclerosis (mean gradient ≤10 mmHg) plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

  • 3

    Patients with normal aortic valve plus angiographically significant coronary artery disease (more than 50% diameter stenosis)

06

Study locations

1 site
  • Charles University of Prague, School of Medicine, Plzen
    Plzen, 304060, Czech Republic
07

References and documents

Publications

  • Linhartova K, Filipovsky J, Cerbak R, Sterbakova G, Hanisova I, Beranek V. Severe aortic stenosis and its association with hypertension: analysis of clinical and echocardiographic parameters. Blood Press. 2007;16(2):122-8. doi: 10.1080/08037050701343241. PubMed 17612911 ↗
  • Ferda J, Linhartova K, Kreuzberg B. Comparison of the aortic valve calcium content in the bicuspid and tricuspid stenotic aortic valve using non-enhanced 64-detector-row-computed tomography with prospective ECG-triggering. Eur J Radiol. 2008 Dec;68(3):471-5. doi: 10.1016/j.ejrad.2007.09.011. Epub 2007 Oct 24. PubMed 17961946 ↗
  • Linhartova K, Beranek V, Sefrna F, Hanisova I, Sterbakova G, Peskova M. Aortic stenosis severity is not a risk factor for poststenotic dilatation of the ascending aorta. Circ J. 2007 Jan;71(1):84-8. doi: 10.1253/circj.71.84. PubMed 17186983 ↗
  • Linhartova K, Veselka J, Sterbakova G, Racek J, Topolcan O, Cerbak R. Parathyroid hormone and vitamin D levels are independently associated with calcific aortic stenosis. Circ J. 2008 Feb;72(2):245-50. doi: 10.1253/circj.72.245. PubMed 18219161 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00375336
Lead sponsor
Charles University, Czech Republic
First posted
Sep 12, 2006
Start date
Jan 2005
Completion
Dec 2008 (estimated)
Last update
Jan 1, 2009

Study contacts

Katerina Linhartova, MD, PhD
principal investigator · Charles University of Prague, School of Medicine Pilsen, Czech Republic
Roman Cerbak, Prof,MD,PhD
study chair · Center for Cardiovascular and Transplantation Surgery, Brno, Czech Republic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Valve Stenosis→

Other studies from this sponsor

Charles University, Czech Republic

Start the discussion