Risk Prediction in Aortic Stenosis

NCT ID: NCT01422044

Last Updated: 2014-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* life expectancy \<1 year due to non-cardiac causes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thebiosignals.com

OTHER

Sponsor Role lead

Responsible Party

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Axel Bauer

Prof. Dr. med. Axel Bauer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medizinische Klinik III

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Zuern CS, Eick C, Rizas KD, Stoleriu C, Barthel P, Scherer C, Muller KA, Gawaz M, Bauer A. Severe autonomic failure in moderate to severe aortic stenosis: prevalence and association with hemodynamics and biomarkers. Clin Res Cardiol. 2012 Jul;101(7):565-72. doi: 10.1007/s00392-012-0427-3. Epub 2012 Feb 24.

Reference Type DERIVED
PMID: 22362502 (View on PubMed)

Other Identifiers

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402/2009BO2-1

Identifier Type: -

Identifier Source: org_study_id

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