NCT01422044

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

4.3 years

First QC Date

July 19, 2011

Last Update Submit

February 5, 2014

Conditions

Aortic Stenosis

Keywords

aortic stenosisautonomic function

Outcome Measures

Primary Outcomes (1)

  • Total mortality

    2 years

Secondary Outcomes (3)

  • Cardiovascular mortality

    2 years

  • Combination of cardiovascular mortality and cardiac adverse events

    2 years

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with at least moderate aortic stenosis

You may qualify if:

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

You may not qualify if:

  • life expectancy \<1 year due to non-cardiac causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik III

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22362502DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Axel Bauer

Study Record Dates

First Submitted

July 19, 2011

First Posted

August 23, 2011

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

DE(1)