Risk Prediction in Aortic Stenosis (PREDICT-AS)
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|ClinicalTrials.gov Identifier: NCT01422044|
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : February 6, 2014
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||423 participants|
|Official Title:||Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- Total mortality [ Time Frame: 2 years ]
- Cardiovascular mortality [ Time Frame: 2 years ]
- Combination of cardiovascular mortality and cardiac adverse events [ Time Frame: 2 years ]
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422044
|Medizinische Klinik III|
|Tübingen, Germany, 72076|