2024-518389-28-00招募中4 期
Impact of an Angiotensin Receptor Blocker in Aortic Stenosis (ARBAS) – A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- The rate of progression of peak aortic velocity (m/s) assessed by echocardiography
研究概览
简要总结
This study is intended to investigate the effect of angiotensin receptor blockers on mild to moderate aortic stenosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with mild-moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s).
- •Age ≥ 20 ≤ 85 years
- •Left ventricular ejection fraction ≥50%
- •Systolic blood pressure ≥100 mmHg
- •Signed informed consent
排除标准
- •More than mild aortic or mitral regurgitation, or mitral stenosis
- •Current use of renin-angiotensin system medication or Aliskiren in patiens with arterial hypertension and diabetes mellitus or arterial hypertension and chronic kidney disease stage 4-5 (estimated glomerular filtration rate <30 ml/min/1.73m2)
- •Known allergy or intolerance to Angiotensin-receptor-blockers, poorly controlled blood pressure
- •Renal dysfunction (glomerular filtration rate <30ml/min/1.73 m2) or chronic hyperkalemia (P-potassium ≥5.5 mmol/l)
- •Hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
- •Newly diagnosed (<2 months) or poorly controlled diabetes; HbA1c >86 mmol/mol (>10%)
- •Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months)
- •Pregnant or lactating women. Fertile women without highly effective birth control method. Patients unable to read, understand or sign research consent
结局指标
主要结局
The rate of progression of peak aortic velocity (m/s) assessed by echocardiography
The rate of progression of peak aortic velocity (m/s) assessed by echocardiography
The rate of progression of aortic valve calcification (AU) assessed by non-contrast computed tomography after 24 months treatment with losartan compared with placebo.
The rate of progression of aortic valve calcification (AU) assessed by non-contrast computed tomography after 24 months treatment with losartan compared with placebo.
次要结局
- Left ventricular geometry and mass (relative wall-thickness, left ventricular mass index) assessed by echocardiography and magnetic resonance imaging after 24 months treatment with losartan compared with placebo treatment.
- Diastolic function assessed by echocardiography
- Markers of left ventricular filling pressures (E/e’, NT-proBNP)
研究者
Mulham Ali
Scientific
Odense University Hospital
研究点 (1)
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