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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04613193
Other study ID # BP-AVALVE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date June 1, 2031

Study information

Verified date October 2020
Source Aarhus University Hospital
Contact Henrik Wiggers, MD, PhD
Email henrikwiggers@dadlnet.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 1, 2031
Est. primary completion date January 1, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Blood presssure reduction
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

Locations

Country Name City State
Denmark 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 Silkeborg Hospital Silkeborg
Denmark Dept. of cardiology, Viborg Hospital Viborg

Sponsors (2)

Lead Sponsor Collaborator
Henrik Wiggers Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in LV mass LV mass as measured by cardiac MR Changes will be evaluated after an expected average of 12 months treatment
Primary 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
Primary 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
Secondary LV mass-cavity ratio. Cardiac MR Through study completion, an average of 1 year
Secondary LV myocardial fibrosis Cardiac MR Through study completion, an average of 1 year
Secondary Myocardial perfusion during rest and stress Cardiac MR Through study completion, an average of 1 year
Secondary Aortic peak and mean gradients Echocardiography Through study completion, an average of 1 year
Secondary Aortic valve area Echocardiography Through study completion, an average of 1 year
Secondary Left ventricular global longitudinal strain Echocardiography Through study completion, an average of 1 year
Secondary Valvolu-arterial impedance Echocardiography Through study completion, an average of 1 year
Secondary NT-proBNP Blood test Baseline and follow-up
Secondary Minnesota living with heart failure questionnaire Questionnaire Through study completion, an average of 1 year
Secondary Ambulatory 24-hour blood pressure measurement Ambulatory 24-hour blood pressure measurement Through study completion, an average of 1 year
Secondary Dimensions and aortic calcium score of the thoracic aorta. cardiac CT Through study completion, an average of 2 years
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