Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenrik Wiggers
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Blood presssure reduction
Other interventionPatients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Strict BP intervention groupActive comparator 1 intervention
Group B: Conventional BP control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in LV mass
LV mass as measured by cardiac MR
Time frame
Changes will be evaluated after an expected average of 12 months treatment2
Change in aortic valve CT calcium volume and aortic peak gradient
Cardiac CT and Echocardiography
Time frame
Changes will be evaluated after an expected average of 2-3 years treatment3
Clinical composite endpoint:
Major cardiovascular events including death from cardiovascular causes, aortic valve replacement, non-fatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary artery bypass surgery, percutaneous coronary intervention, and haemorrhagic and non-haemorrhagic stroke, new onset atrial fibrillation.
Time frame
Will be evaluated after an expected average of 7-13 years of treatmentSecondary outcomes
1
LV mass-cavity ratio.
Cardiac MR
Time frame
Through study completion, an average of 1 year2
LV myocardial fibrosis
Cardiac MR
Time frame
Through study completion, an average of 1 year3
Myocardial perfusion during rest and stress
Cardiac MR
Time frame
Through study completion, an average of 1 year4
Aortic peak and mean gradients
Echocardiography
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henrik Wiggers
Lead sponsor
Aarhus University Hospital
Sponsor institution
Danish Heart Foundation
Collaborator
Source ClinicalTrials.gov