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NCT02510482 Clinical Trial

Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:
Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02510482
Other study ID # METC 15-2-023
Secondary ID
Status Completed
Phase N/A
First received July 27, 2015
Last updated October 16, 2017
Start date August 2015
Est. completion date October 16, 2017

Study information
Verified date September 2016
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Calcified aortic valve stenosis (CAVS) is a progressive disease and nowadays, the cornerstone in diagnostics and follow-up is echocardiography. Cardiac biomarkers (such as cardiac troponins T and I and NT-pro-BNP) hold promise to fulfil a role in early recognition of complications concerning the aortic valve and decompensation. For this purpose, it is important to assess the normal biological variation (BV) of cardiac biomarkers in CAVS. The assessment of biological variation will contribute to a better understanding of fluctuation of cardiac biomarkers in subjects with stable CAVS. These data will improve monitoring of CAVS using cardiac biomarkers.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date October 16, 2017
Est. primary completion date October 16, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinically stable moderate aortic valve stenosis

- No evidence of acute cardiovascular disease

Exclusion Criteria:

- Acute myocardial infarction in the last six months

- Pulmonary embolism in the last six months

- Hospitalisation for heart failure in the last six months

- Chronic kidney disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention

Locations
Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac troponin T One year
Primary Cardiac troponin I One year
Primary NT-pro-BNP One year
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