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| Name | Class |
|---|---|
| Danish Heart Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict BP intervention group | Active Comparator | SBP < 120 mmHg and a reduction in SBP of >= 15 mmHg |
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| Conventional BP control group | Other | In patients < 75 years: SBP = 135 mmHg In patients >/= 75 years: SBP = 145 mmHg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood presssure reduction | Other | Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in LV mass | LV mass as measured by cardiac MR | Changes will be evaluated after an expected average of 12 months treatment |
| Change in aortic valve CT calcium volume and aortic peak gradient | Cardiac CT and Echocardiography | Changes will be evaluated after an expected average of 2-3 years treatment |
| 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. | Will be evaluated after an expected average of 7-13 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| LV mass-cavity ratio. | Cardiac MR | Through study completion, an average of 1 year |
| LV myocardial fibrosis | Cardiac MR | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Wiggers, MD, PhD | Contact | henrikwiggers@dadlnet.dk | ||
| Jonas A Povlsen, MD | Contact | +452270282 | jonapovl@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Wiggers | Aarhus University Hospital, Department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99 | Recruiting | Aarhus | Denmark |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000075222 | Essential Hypertension |
| D006333 | Heart Failure |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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1. BP-AVALVE I: 60 patients will be randomized (1:1) to either strict BP control (N=30) or conventional treatment (N=30). Treatment period will be 12 months.
2. BP-AVALVE II: 200 patients will be randomized (1:1) to either strict BP control as in study 1 (N=100) or conventional care as in study 1 (N=100). Average treatment period will be 2 (1-3) years.
3. BP-AVALVE III: Patients from BP-AVALVE-II continue in the randomized design until they develop symptoms of AS or have been followed for 10 (7-13) years. Patients will be reexamined at the end of the study period or in case they develop symptoms or LV failure and thus indication of valve replacement.
Since the medicinal products used in this study is not the subject of the trial, the Danish Medicines Agency has classified this study as a clinical trial, in which medicinal products are used as a tool to induce a well-known physiological response. Therefor no further approval from the Danish Medicine Agency is required.
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| Myocardial perfusion during rest and stress | Cardiac MR | Through study completion, an average of 1 year |
| Aortic peak and mean gradients | Echocardiography | Through study completion, an average of 1 year |
| Aortic valve area | Echocardiography | Through study completion, an average of 1 year |
| Left ventricular global longitudinal strain | Echocardiography | Through study completion, an average of 1 year |
| Valvolu-arterial impedance | Echocardiography | Through study completion, an average of 1 year |
| NT-proBNP | Blood test | Baseline and follow-up |
| Minnesota living with heart failure questionnaire | Questionnaire | Through study completion, an average of 1 year |
| Ambulatory 24-hour blood pressure measurement | Ambulatory 24-hour blood pressure measurement | Through study completion, an average of 1 year |
| Dimensions and aortic calcium score of the thoracic aorta. | cardiac CT | Through study completion, an average of 2 years |
| Dept. of Cardiology, Herning Hospital | Not yet recruiting | Herning | Denmark |
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| Dept. of cardiology, Horsens Hospital | Not yet recruiting | Horsens | Denmark |
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| Dept. of cardiology, Randers Hospital | Not yet recruiting | Randers | Denmark |
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| Silkeborg Hospital | Not yet recruiting | Silkeborg | Denmark |
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| Dept. of cardiology, Viborg Hospital | Not yet recruiting | Viborg | Denmark |
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| D014694 |
| Ventricular Outflow Obstruction |
| D014652 | Vascular Diseases |