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Risk Prediction in Aortic Stenosis

Risk Prediction in Aortic Stenosis by Cardiac Autonomic Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01422044
Acronym
PREDICT-AS
Enrollment
423
Registered
2011-08-23
Start date
2009-09-30
Completion date
2014-01-31
Last updated
2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

aortic stenosis, autonomic function

Brief summary

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

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.

Interventions

None listed

Sponsors

Thebiosignals.com
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Total mortality2 years

Secondary

MeasureTime frameDescription
Cardiovascular mortality2 years
Combination of cardiovascular mortality and cardiac adverse events2 years
Correlation of presence of autonomic dysfunction with severity of aortic stenosisat time of cardiac catheterization, which will be performed at an expected average of 3 days after hospital admissionIt 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026