Impact of Angiotensin Receptor Blockers in Aortic Stenosis - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change in the anatomic progression of aortic stenosis
研究概览
简要总结
This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.
详细描述
Studies support the concept that activation of the renin-angiotensin system may be involved in the progression of valve stenosis and myocardial fibrosis in aortic stenosis. Furthermore recent studies have shown that renin-angiotensin system medication may slow down aortic stenosis progression rate and left ventricle remodeling.
Thus the present study is a randomized control trial to test the efficacy of the angiotensin receptor blocker (ARB) to slow down aortic stenosis progression and left ventricular remodeling/dysfunction in patients with mild-to-moderate aortic stenosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)
- •Normal left ventricular ejection fraction (i.e. ≥50%)
- •Systolic blood pressure >110 mmHg
- •Diastolic blood pressure >70 mmHg
排除标准
- •More than mild aortic or mitral regurgitation, or mitral stenosis
- •Current use or documented indication for renin-angiotensin system medication or Aliskiren
- •Known allergy or intolerance to angiotensin II receptor blockers (ARBs)
- •Alzheimer, dementia or known non-compliant patient
- •Renal dysfunction (glomerular filtration rate <30ml/min/1.73m2)
- •Chronic hyperkalemia
- •Diagnosed hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
- •Newly diagnosed (<2 months) or poorly controlled diabetes
- •Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months)
- •Pregnant or lactating women
- •Patients unable to read, understand or sign research consent
研究组 & 干预措施
Angiotensin Receptor Blockers
Angiotensin Receptor Blockers will be given orally once a day for 2 years.
干预措施: Angiotensin Receptor Blockers (Drug)
Placebo
Participants will receive a matched placebo orally once a day for 2 years.
干预措施: Placebo (Other)
结局指标
主要结局
Change in the anatomic progression of aortic stenosis
时间窗: Baseline, 2 years
Aortic valve calcification (measured by MDCT)
次要结局
- Change in peak aortic jet velocity(Baseline, 2 years)
- Change in aortic valve area(Baseline, 2 years)
- Change in left ventricular (LV) dimension(Baseline, 2 years)
- Change in left ventricular (LV) mass(Baseline, 2 years)
- Change in left ventricular (LV) fibrosis(Baseline, 2 years)
研究者
Marie-Annick Clavel
Full Professor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval