Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Change in LV mass
研究概览
简要总结
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:
- Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment.
- Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment.
- Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Conventional BP control group
In patients < 75 years: SBP = 135 mmHg In patients >/= 75 years: SBP = 145 mmHg
干预措施: Blood presssure reduction (Other)
Strict BP intervention group
SBP < 120 mmHg and a reduction in SBP of >= 15 mmHg
干预措施: Blood presssure reduction (Other)
结局指标
主要结局
Change in LV mass
时间窗: Changes will be evaluated after an expected average of 12 months treatment
LV mass as measured by cardiac MR
Clinical composite endpoint:
时间窗: 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.
Change in aortic valve CT calcium volume and aortic peak gradient
时间窗: Changes will be evaluated after an expected average of 2-3 years treatment
Cardiac CT and Echocardiography
次要结局
- LV myocardial fibrosis(Through study completion, an average of 1 year)
- Aortic peak and mean gradients(Through study completion, an average of 1 year)
- Myocardial perfusion during rest and stress(Through study completion, an average of 1 year)
- Valvolu-arterial impedance(Through study completion, an average of 1 year)
- Ambulatory 24-hour blood pressure measurement(Through study completion, an average of 1 year)
- LV mass-cavity ratio.(Through study completion, an average of 1 year)
- Left ventricular global longitudinal strain(Through study completion, an average of 1 year)
- Minnesota living with heart failure questionnaire(Through study completion, an average of 1 year)
- Dimensions and aortic calcium score of the thoracic aorta.(Through study completion, an average of 2 years)
- Aortic valve area(Through study completion, an average of 1 year)
- NT-proBNP(Baseline and follow-up)
研究者
Henrik Wiggers
Consultant, Associate professor, MD, PhD, DMSc
Aarhus University Hospital