Skip to main content
OpenTrials
Completed

NCT Number: NCT01422044

Risk Prediction in Aortic Stenosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Klinik III

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Total mortality

    Time frame: 2 years

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 2 years

  2. Combination of cardiovascular mortality and cardiac adverse events

    Time frame: 2 years

  3. 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.

Sponsors and collaborators

Lead sponsor

Thebiosignals.com

Other

Registry information

Official study title

Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

Acronym: PREDICT-AS

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2011
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.