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Risk Prediction in Aortic Stenosis (PREDICT-AS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axel Bauer, Thebiosignals.com
ClinicalTrials.gov Identifier:
NCT01422044
First received: July 19, 2011
Last updated: February 5, 2014
Last verified: February 2014
  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 Thebiosignals.com:

Primary Outcome Measures:
  • Total mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Combination of cardiovascular mortality and cardiac adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422044

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

No publications provided by Thebiosignals.com

Additional 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
Study First Received: July 19, 2011
Last Updated: February 5, 2014
Health Authority: Germany: Ethics Committee

Keywords provided by Thebiosignals.com:
aortic stenosis
autonomic function

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

ClinicalTrials.gov processed this record on November 25, 2014