Risk Prediction in Aortic Stenosis
- Conditions
- Aortic Stenosis
- Registration Number
- NCT01422044
- Lead Sponsor
- Thebiosignals.com
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 423
- Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg
- life expectancy <1 year due to non-cardiac causes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total mortality 2 years
- Secondary Outcome Measures
Name Time Method 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 It will be assessed whether patients with cardiac autonomic dysfunction have more severe aortic stenosis.
Autonomic dysfunction will assumed to be present when patients suffer from "severe autonomic failure" (i.e. combination of abnormal Heart Rate Turbulence and Deceleration Capacity).
Severity of aortic stenosis will be assessed by clinical (symptoms, NYHA class), hemodynamic (mean aortic gradient, aortic valve area) and biochemical (Nt-BNP, high sensitive troponins) markers.
Trial Locations
- Locations (1)
Medizinische Klinik III
🇩🇪Tübingen, Germany