Clincosm LogoSign in Get a demo

PREDICT-AS: Risk Prediction in Aortic Stenosis

Sponsor
Thebiosignals.com (Other)
Overall Status
Completed
CT.gov ID
NCT01422044
Collaborator
(none)
423
Enrollment
1
Location
52
Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    423 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    Jan 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Total mortality [2 years]

    Secondary Outcome Measures

    1. Cardiovascular mortality [2 years]

    2. Combination of cardiovascular mortality and cardiac adverse events [2 years]

    3. Correlation of presence of autonomic dysfunction with severity of aortic stenosis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Medizinische Klinik III Tübingen Germany 72076

    Sponsors and Collaborators

    • Thebiosignals.com

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Axel Bauer, Prof. Dr. med. Axel Bauer, Thebiosignals.com
    ClinicalTrials.gov Identifier:
    NCT01422044
    Other Study ID Numbers:
    • 402/2009BO2-1
    First Posted:
    Aug 23, 2011
    Last Update Posted:
    Feb 6, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Axel Bauer, Prof. Dr. med. Axel Bauer, Thebiosignals.com
    aortic stenosis
    autonomic function
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Feb 6, 2014