Actively Recruiting
Study Comparing Strict Versus Conventional Blood Pressure Control in Adults with Asymptomatic Moderate to Severe Aortic Valve Stenosis
Led by Henrik Wiggers · Updated on 2020-11-03
200
Participants Needed
6
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of strict blood pressure control compared to conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. This randomized, open-label intervention trial aims to study whether strict blood pressure management can reduce heart muscle changes, slow aortic valve calcification, and lower the need for valve replacement and cardiovascular events over time. Participants are assigned to one of two groups a strict blood pressure intervention group targeting a systolic blood pressure SBP below 120 mmHg with at least a 15 mmHg reduction, or a conventional blood pressure control group targeting SBP of 135 mmHg for those under 75 years and 145 mmHg for those 75 years or older. Antihypertensive treatments are adjusted to reach these targets. The study includes treatment periods lasting from 12 months up to 10 years to assess different outcomes. During the trial, participants undergo various assessments including measurements of left ventricular mass, aortic valve calcium volume, heart function tests, blood pressure monitoring, and quality of life questionnaires. These evaluations occur at different time points ranging from one year to over a decade. Researchers will monitor clinical events and heart remodeling changes to determine the impact of strict blood pressure control. The total duration of participation may last up to 13 years with ongoing follow-up.
CONDITIONS
Brief Title
Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
Research Team
H
Henrik Wiggers, MD, PhD
J
Jonas A Povlsen, MD
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