NCT00693797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

2.9 years

First QC Date

June 5, 2008

Last Update Submit

April 27, 2009

Conditions

Aortic Stenosis

Keywords

ventricular hypertrophycollagenaortic stenosis

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up.

    one year

Study Arms (2)

I, observation

patients with aortic stenosis

II, observation

patients with aortic stenosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with aortic stenosis and left ventricular hypertrophy

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty hospital Královské Vinohrady

Prague, 100 34, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen serum for collagen metabolism detection

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jirmář Radovan, M.D., Ph.D.

    Faculty hospital Královské Vinohrady

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

CZ(1)