Risk Prediction in Aortic Stenosis (PREDICT-AS)
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function|
- Total mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Cardiovascular mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Combination of cardiovascular mortality and cardiac adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Correlation of presence of autonomic dysfunction with severity of aortic stenosis [ Time Frame: at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission ] [ Designated as safety issue: No ]
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.
|Study Start Date:||September 2009|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422044
|Medizinische Klinik III|
|Tübingen, Germany, 72076|