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Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis

NCT ID: NCT02510482

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Keywords

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cardiac biomarkers

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic valve stenosis

Individuals with clinically stable moderate aortic valve stenosis

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 24583293 (View on PubMed)

Peeters 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.

Reference Type DERIVED
PMID: 31168392 (View on PubMed)

Other Identifiers

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METC 15-2-023

Identifier Type: -

Identifier Source: org_study_id