Risk Prediction in Aortic Stenosis (PREDICT-AS)

February 5, 2014 updated by: Axel Bauer, Thebiosignals.com

Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • Medizinische Klinik Iii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with at least moderate aortic stenosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 2 years
2 years
Combination of cardiovascular mortality and cardiac adverse events
Time Frame: 2 years
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.
at time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thebiosignals.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

August 21, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 402/2009BO2-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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