No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Henrik Wiggers · Other
Who this trial is looking for
This trial is looking for patients with asymptomatic aortic valve stenosis to compare strict blood pressure control with standard care. Participants will be monitored to see how effective this approach is over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have aortic valve peak velocity between 3.0 and 5.0 m/s or aortic valve area of 1.2 cm2 or less.
I have a systolic blood pressure of at least 127 mmHg.
I have a heart function measurement of 50% or more.
I am over 18 years old.
I am using safe birth control if I can become pregnant.
I have tested negative for pregnancy.
I can understand the study information and give consent.
You may not be able to join if
I have symptoms related to aortic stenosis.
I have low blood pressure when standing.
I am suspected of having secondary hypertension.
I am participating in another randomized drug study.
I have moderate to severe aortic valve regurgitation.
I have known or suspected heart disease.
I have significant coronary blockages requiring treatment.
My kidney function is severely reduced.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 co…
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.
Trial Locations
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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,…
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% stenosis in a major epicardial vessel, symptoms or signs of myocardial ischemia, e.g. angina pectoris, wall motion abnormalities). Patients who have previously undergone complete revascularization of major coronary arteries due to angina pectoris are eligible for inclusion.
* Significant coronary obstructive lesions detected by baseline Cardiac CT that requires a revascularisation procedure.
* eGFR \< 30 ml/min or end-stage renal disease
* Other disease, comorbidity or treatment making the subject unsuitable for study participation as judged by the investigator
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