NCT01422044CompletedNot Applicable
Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function
Thebiosignals.com1 site in 1 country423 target enrollmentStarted: September 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 423
- Locations
- 1
- Primary Endpoint
- Total mortality
Study Overview
Brief Summary
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.
Detailed Description
Autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity).
Autonomic function will also be assessed by respiration and repolarization abnormalities.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg
Exclusion Criteria
- •life expectancy <1 year due to non-cardiac causes
Outcomes
Primary Outcomes
Total mortality
Time Frame: 2 years
Secondary Outcomes
- Cardiovascular mortality(2 years)
- Combination of cardiovascular mortality and cardiac adverse events(2 years)
- Correlation of presence of autonomic dysfunction with severity of aortic stenosis(at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission)
Investigators
Axel Bauer
Prof. Dr. med. Axel Bauer
Thebiosignals.com
Study Sites (1)
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