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Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

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ClinicalTrials.gov Identifier: NCT02510482
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Other: No intervention

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Aortic valve stenosis
Individuals with clinically stable moderate aortic valve stenosis
Other: No intervention



Primary Outcome Measures :
  1. Cardiac troponin T [ Time Frame: One year ]
  2. Cardiac troponin I [ Time Frame: One year ]
  3. NT-pro-BNP [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with clinically stable moderate aortic valve stenosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510482


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02510482    
Other Study ID Numbers: METC 15-2-023
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: September 2016
Keywords provided by Maastricht University Medical Center:
cardiac biomarkers
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction