Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2017
CompletedOctober 18, 2017
September 1, 2016
2.2 years
July 27, 2015
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cardiac troponin T
One year
Cardiac troponin I
One year
NT-pro-BNP
One year
Study Arms (1)
Aortic valve stenosis
Individuals with clinically stable moderate aortic valve stenosis
Interventions
Eligibility Criteria
Individuals with clinically stable moderate aortic valve stenosis
You may qualify if:
- Clinically stable moderate aortic valve stenosis
- No evidence of acute cardiovascular disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Center
Maastricht, Netherlands
Related Publications (2)
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.
PMID: 24583293BACKGROUNDPeeters FECM, Kietselaer BLJH, Hilderink J, van der Linden N, Niens M, Crijns HJGM, Meex SJR. Biological variation of cardiac markers in patients with aortic valve stenosis. Open Heart. 2019 May 8;6(1):e001040. doi: 10.1136/openhrt-2019-001040. eCollection 2019.
PMID: 31168392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2015
First Posted
July 29, 2015
Study Start
August 1, 2015
Primary Completion
October 16, 2017
Study Completion
October 16, 2017
Last Updated
October 18, 2017
Record last verified: 2016-09