Risk Prediction in Aortic Stenosis

Aortic Stenosis Clinical Trial

— PREDICT-AS  

Official title:

Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422044
• Other study ID #: 402/2009BO2-1
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: February 5, 2014
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Thebiosignals.com
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Aortic valve area =1.5 qcm or mean aortic gradient =25mmHg

Exclusion Criteria:

• life expectancy <1 year due to non-cardiac causes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Germany	Medizinische Klinik III	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Thebiosignals.com

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality		2 years	No
Secondary	Cardiovascular mortality		2 years	No
Secondary	Combination of cardiovascular mortality and cardiac adverse events		2 years	No
Secondary	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.	at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission	No