Blood presssure reduction
OtherPatients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
NCT Number: NCT04613193
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
Time frame: Changes will be evaluated after an expected average of 12 months treatment
LV mass as measured by cardiac MR
Time frame: Changes will be evaluated after an expected average of 2-3 years treatment
Cardiac CT and Echocardiography
Time frame: Will be evaluated after an expected average of 7-13 years of treatment
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: Through study completion, an average of 1 year
Cardiac MR
Time frame: Through study completion, an average of 1 year
Cardiac MR
Time frame: Through study completion, an average of 1 year
Cardiac MR
Time frame: Through study completion, an average of 1 year
Echocardiography
Time frame: Through study completion, an average of 1 year
Echocardiography
Time frame: Through study completion, an average of 1 year
Echocardiography
Time frame: Through study completion, an average of 1 year
Echocardiography
Time frame: Baseline and follow-up
Blood test
Time frame: Through study completion, an average of 1 year
Questionnaire
Time frame: Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement
Time frame: Through study completion, an average of 2 years
cardiac CT
Contact information is provided by the study sponsor or research team.
Henrik Wiggers, MD, PhD
CONTACT
Jonas A Povlsen, MD
CONTACT
Henrik Wiggers
Other
Acronym: BP-AVALVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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