To study the biological variation of cardiac biomarkers (e.g. cardiac troponin T and I, NT-pro-BNP, ST-2, Galectin-3) in clinically stable moderate aortic valve stenosis.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentrations of cardiac biomarkers (eg troponins, NT-pro-BNP, ST-2 and
galectin-3) measured 7 times within 1 year.
Secondary outcome
Not applicable.
Background 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 patients with CAVS. This will
contribute to a better understanding of the fluctuation of biomarkers in the
absence of acute myocardial infarction in subjects with stable CAVS. This study
will assess the biological variation of cardiac biomarkers in stable CAVS.
Study objective
To study the biological variation of cardiac biomarkers (e.g. cardiac troponin
T and I, NT-pro-BNP, ST-2, Galectin-3) in clinically stable moderate aortic
valve stenosis.
Study design
Observational study consisting of 7 short visits (at inclusion, 1 day, 1 week,
1 month, 3 months, 6 months and 1 year) at the same time of the day for blood
sampling through venepuncture.
Study burden and risks
During the study, subjects will visit the hospital 7 times within 1 year (at
inclusion, 1 day, 1 week, 1/3/6 months and 1 year). During the short visits (at
inclusion, 3 months, 6 months and 1 year), subjects will complete a medical
questionnaire to assess their cardiovascular health status and venous sampling
will be performed through venepuncture during every visit (7 times, 20 ml each
time). The risks associated with the proposed study are low. A hematoma could
occur as a result of the venepunctures.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Individuals (aged * 18 years) with clinically stable moderate aortic valve stenosis, defined by serial Doppler echocardiographic measurements of maximum transvalvular velocity (Vmax), mean pressure gradient (PGmean), and Aortic Valve Area (AVA) and a preserved ejection fraction (EF), will be recruited to participate in this study. Only subjects who are able to provide informed consent will be included.
Exclusion criteria
Subjects with severe aortic valve stenosis
Subjects with clinically progressive aortic valve stenosis
Subjects with documented atrial fibrillation in the last year. (subjects are allowed to have a history of atrial fibrillation)
Subjects with acute myocardial infarction in the last 6 months
Subjects with hospitalisation for heart failure in the last 6 months
Subjects with pulmonary embolism in the last 6 months
Subjects with chronic kidney disease (CKD)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53223.068.15 |