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
639 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
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.
CONDITIONS
Official 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) 1.2 cm2
- Blood pressure: SBP 127 mmHg measured by BP-TRU
- Left ventricular ejection fraction (LVEF) 50%
- Age 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 provide informed consent
You will not qualify if you...
- Symptoms due to aortic valve stenosis
- Symptomatic orthostatic hypotension and/or one minute standing SBP 110 mmHg
- Suspicion of secondary hypertension
- Participation in other randomized drug studies (device studies accepted)
- Moderate to severe aortic valve regurgitation (e.g., vena contracta 5 mm)
- Known or suspected ischemic heart disease with significant coronary artery stenosis
- Significant coronary lesions requiring revascularization detected by baseline cardiac CT
- eGFR 30 ml/min or end-stage renal disease
- Other diseases or conditions making study participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
J
Jonas A Povlsen, MD
CONTACT
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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