Actively Recruiting
Blood Pressure Reduction in Patients With Asymptomatic Aortic Valve Stenosis
Led by Henrik Wiggers · Updated on 2020-11-03
200
Participants Needed
6
Research Sites
21 weeks
Total Duration
On this page
Sponsors
H
Henrik Wiggers
Lead Sponsor
D
Danish Heart Foundation
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) 6 1.2 cm2
- Systolic blood pressure (SBP) 27 127 mmHg measured by BP-TRU
- Left ventricular ejection fraction (LVEF) 5 50%
- Age greater than 18 years
- Safe birth control management for women of childbearing potential
- Negative urine-HCG test for women of childbearing potential
- Ability to understand written patient information and give informed consent
You will not qualify if you...
- Symptoms due to aortic valve stenosis
- Symptomatic orthostatic hypotension or one minute standing SBP less than 110 mmHg
- Suspicion of secondary hypertension
- Participation in other randomized drug studies (device studies allowed)
- Moderate to severe aortic valve regurgitation
- Known or suspected ischemic heart disease without complete revascularization
- Significant coronary lesions requiring revascularization
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min or end-stage renal disease
- Other diseases or treatments making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 13 years
Participants receive antihypertensive treatment that is adjusted to achieve specific blood pressure targets depending on their assigned group.
Regular visits to monitor blood pressure and adjust medication as needed
Trial Site Locations
Total: 6 locations
1
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
Aarhus, Denmark
Actively Recruiting
2
Dept. of Cardiology, Herning Hospital
Herning, Denmark
Not Yet Recruiting
3
Dept. of cardiology, Horsens Hospital
Horsens, Denmark
Not Yet Recruiting
4
Dept. of cardiology, Randers Hospital
Randers, Denmark
Not Yet Recruiting
5
Silkeborg Hospital
Silkeborg, Denmark
Not Yet Recruiting
6
Dept. of cardiology, Viborg Hospital
Viborg, Denmark
Not Yet Recruiting
Research Team
H
Henrik Wiggers, MD, PhD
J
Jonas A Povlsen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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