RecruitingNot ApplicableNCT04613193

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis


Sponsor

Henrik Wiggers

Enrollment

200 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lowering blood pressure in patients with moderate aortic valve narrowing (stenosis) — who do not yet have symptoms — can slow the progression of the valve disease and prevent complications. **You may be eligible if...** - You have moderate narrowing of your aortic heart valve (confirmed by echocardiogram) - Your systolic blood pressure is 127 mmHg or higher - Your heart pumping function is normal (ejection fraction ≥ 50%) - You are 18 or older - Women of childbearing age must use reliable contraception and have a negative pregnancy test **You may NOT be eligible if...** - You already have symptoms from your aortic valve disease (chest pain, fainting, shortness of breath) - You have significant dizziness or low blood pressure when standing - You are suspected to have secondary causes of high blood pressure - You are participating in another drug study - You are pregnant or may become pregnant without appropriate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood presssure reduction

Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.


Locations(6)

Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99

Aarhus, Denmark

Dept. of Cardiology, Herning Hospital

Herning, Denmark

Dept. of cardiology, Horsens Hospital

Horsens, Denmark

Dept. of cardiology, Randers Hospital

Randers, Denmark

Silkeborg Hospital

Silkeborg, Denmark

Dept. of cardiology, Viborg Hospital

Viborg, Denmark

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NCT04613193


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