Heart Failure Clinical Trial
— BP-AVALVEOfficial title:
Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Henrik Wiggers | Danish Heart Foundation |
Denmark,
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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