Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • Blood presssure reduction

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

6
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99 Aarhus Denmark
Dept. of Cardiology, Herning Hospital Herning Denmark
Dept. of cardiology, Horsens Hospital Horsens Denmark
Dept. of cardiology, Randers Hospital Randers Denmark

Sponsors and collaborators

Henrik Wiggers

Lead sponsor

Aarhus University Hospital

Sponsor institution

Danish Heart Foundation

Collaborator

Source ClinicalTrials.gov