Risk Prediction in Aortic Stenosis

N/ACompletedNCT01422044

Thebiosignals.com423 enrolled

Overview

The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

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

Enrollment

423

Conditions

Aortic Stenosis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmHg Exclusion Criteria: * life expectancy \<1 year due to non-cardiac causes

Locations (1)

Medizinische Klinik III

Tübingen, Germany

Outcomes

Primary Outcomes

Total mortality

Time frame: 2 years

Secondary Outcomes

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

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.

Time frame: at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission

Data from ClinicalTrials.gov

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