NCT04613193 Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2 cm2 * Blood pressure: SBP \>= 127 mmHg measured by BP-TRU * LVEF ≥ 50% * Age \> 18 years * Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) for women of childbearing potential. * Negative urine-HCG for women of childbearing potential * Ability to understand the written patient information and to give informed consent. Exclusion Criteria: * Symptoms due to AS * Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16). * Suspicion of secondary hypertension * Participation in other randomized drug study (device studies accepted) * Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography) * Known or suspected ischemic heart disease (coronary angiography with \>70% ste

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