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OpenTrials
Completed

NCT Number: NCT02510482

Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Cardiac troponin T

    Time frame: One year

  2. Cardiac troponin I

    Time frame: One year

  3. NT-pro-BNP

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 29, 2015
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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