The aim of this study is to investigate the effect of strict blood pressure control versus conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. The study is a randomized (1:1), open label, controlled intervention trial. Hypothesis: 1. Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment. 2. Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment. 3. Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
Aarhus, Denmark
RECRUITINGDept. of Cardiology, Herning Hospital
Herning, Denmark
NOT_YET_RECRUITINGDept. of cardiology, Horsens Hospital
Horsens, Denmark
NOT_YET_RECRUITINGDept. of cardiology, Randers Hospital
Randers, Denmark
NOT_YET_RECRUITINGSilkeborg Hospital
Silkeborg, Denmark
NOT_YET_RECRUITINGDept. of cardiology, Viborg Hospital
Viborg, Denmark
NOT_YET_RECRUITINGChange in LV mass
LV mass as measured by cardiac MR
Time frame: Changes will be evaluated after an expected average of 12 months treatment
Change in aortic valve CT calcium volume and aortic peak gradient
Cardiac CT and Echocardiography
Time frame: Changes will be evaluated after an expected average of 2-3 years treatment
Clinical composite endpoint:
Major cardiovascular events including death from cardiovascular causes, aortic valve replacement, non-fatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary artery bypass surgery, percutaneous coronary intervention, and haemorrhagic and non-haemorrhagic stroke, new onset atrial fibrillation.
Time frame: Will be evaluated after an expected average of 7-13 years of treatment
LV mass-cavity ratio.
Cardiac MR
Time frame: Through study completion, an average of 1 year
LV myocardial fibrosis
Cardiac MR
Time frame: Through study completion, an average of 1 year
Myocardial perfusion during rest and stress
Cardiac MR
Time frame: Through study completion, an average of 1 year
Aortic peak and mean gradients
Echocardiography
Time frame: Through study completion, an average of 1 year
Aortic valve area
Echocardiography
Time frame: Through study completion, an average of 1 year
Left ventricular global longitudinal strain
Echocardiography
Time frame: Through study completion, an average of 1 year
Valvolu-arterial impedance
Echocardiography
Time frame: Through study completion, an average of 1 year
NT-proBNP
Blood test
Time frame: Baseline and follow-up
Minnesota living with heart failure questionnaire
Questionnaire
Time frame: Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement
Ambulatory 24-hour blood pressure measurement
Time frame: Through study completion, an average of 1 year
Dimensions and aortic calcium score of the thoracic aorta.
cardiac CT
Time frame: Through study completion, an average of 2 years
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