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Risk Prediction in Aortic Stenosis (PREDICT-AS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422044
First Posted: August 23, 2011
Last Update Posted: February 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axel Bauer, Thebiosignals.com
  Purpose
The purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

Condition
Aortic Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

Resource links provided by NLM:


Further study details as provided by Axel Bauer, Thebiosignals.com:

Primary Outcome Measures:
  • Total mortality [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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.



Enrollment: 423
Study Start Date: September 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with at least moderate aortic stenosis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • life expectancy <1 year due to non-cardiac causes
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Germany
Medizinische Klinik III
Tübingen, Germany, 72076
Sponsors and Collaborators
Thebiosignals.com
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Bauer, Prof. Dr. med. Axel Bauer, Thebiosignals.com
ClinicalTrials.gov Identifier: NCT01422044     History of Changes
Other Study ID Numbers: 402/2009BO2-1
First Submitted: July 19, 2011
First Posted: August 23, 2011
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Axel Bauer, Thebiosignals.com:
aortic stenosis
autonomic function

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction