Acute Haemodynamic Effects of Treatment With ACE-Inhibitors in Patients With Symptomatic Aortic Stenosis (ACCESS)
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis.
研究概览
简要总结
Abundant evidence suggests that Angiotensin Converting Enzyme (ACE) inhibition potentially could reduce the hazardous effects of aortic stenosis and improve haemodynamics. The treatment seems safe even in patients with severe stenosis. There are however no randomised clinical trials that can confirm this hypothesis.
详细描述
Traditionally vasodilators are contraindicated in patients with aortic stenosis. Although no controlled data exists it is believed to be hazardous to reduce afterload, including treatment with angiotensin converting enzyme (ACE) inhibitors, in these patients with aortic stenosis due to the risk of increased transaortic gradient and thus severe hypotension and myocardial hypoperfusion. There is now growing evidence both experimental and clinical that ACE inhibition could have beneficial effects on left ventricular hypertrophy, diastolic function, acute, and possibly chronic haemodynamic parameters in patients with aortic stenosis.
There is, however, a lack of clinical randomized trials that could confirm these findings.
Aims
Prospective double blinded randomised study investigating the safety and effects of treatment with ACE-inhibitor in patients with severe aortic stenosis. Effects will be measured on :
- Invasive measured haemodynamic parameters (Swann-Ganz)
- Working capacity
- Diastolic and systolic function (measured with tissue Doppler echocardiography)
- Blood pressure
- B-type natriuretic peptide (BNP)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valvular aortic stenosis with a aortic valve area < 1, 0 cm2
- •Age > 18 years
- •Willingness to give written informed consent
- •For patients with symptomatic aortic stenosis at least one of following:
- •Stable angina pectoris
- •Syncope at exertion
- •Dizziness at exertion
- •Previous pulmonary oedema
- •Patients in New York Heart Association functional class II-IV
排除标准
- •Sitting systolic pressure < 100 mmHg
- •Creatinine > 200 mM at screening
- •Renal artery stenosis
- •Pregnancy or planned pregnancy
- •Participation in other studies
- •Any patient characteristic that may interfere with compliance with the study protocol
- •Treated with ACE-inhibitor or angiotensin receptor blocker within the last month
- •Known allergy to ACE-inhibitors
研究组 & 干预措施
1
Captopril test dose and Trandolapril
干预措施: Captopril and Trandolapril (Drug)
1
Captopril test dose and Trandolapril
干预措施: Captopril Test Dose and Trandolapril (Drug)
2
干预措施: Captopril and Trandolapril (Drug)
2
干预措施: Captopril Test Dose and Trandolapril (Drug)
结局指标
主要结局
Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis.
时间窗: 8 weeks
次要结局
- Treatment with ACE-inhibitors:(8 weeks)
- Increases working capacity in patients with severe aorta stenosis.(8 weeks)
- Improves systolic and diastolic function on left ventricle.(8 weeks)
- In patients with severe aortic stenosis is safe.(8 weeks)
- Degrease wall stress in left ventricle.(8 weeks)