Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.
研究概览
简要总结
Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery pressure and improve exercise performance in patients with left-sided heart failure, but this has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will produce a clinically significant decrease in pulmonary artery pressure in patients with severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in pulmonary artery pressure will be safe and well tolerated in patients with and without a depressed ejection fraction.
详细描述
Patients with severe aortic stenosis referred for a clinically ordered right and left heart catheterization will be eligible. Twenty subjects will be enrolled: 10 patients will receive 40mg and 10 patients will receive 80mg; each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF. Subjects will get a baseline echo prior to the heart catheterization. Baseline invasive hemodynamic measurements will be performed using a Swan Ganz catheter. A single oral dose of sildenafil will then be administered (40mg or 80mg), followed by invasive hemodynamic measurements at 30 and 60 minutes. Also at 60 minutes, limited echocardiographic images will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Severe aortic stenosis (AVA < 1.0 cm2)
- •Referred for a clinically ordered right and left heart catheterization
- •18 years of age and older
- •Able and willing to comply with all requirements of the study
排除标准
- •Nitrate use within 24 hours
- •SBP < 110 mmHg or MAP < 75 mmHg
- •Severe mitral regurgitation
- •Severe aortic regurgitation
- •Increased risk of priapism
- •Retinal or optic nerve problems or unexplained visual disturbance
- •Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours
- •Current or recent (≤ 30 days) acute coronary syndrome
- •O2 sat < 90% on room air
- •Females that are pregnant or believe they may be pregnant
- •Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable hemodynamic data
- •Unwilling to provide informed consent
研究组 & 干预措施
Sildenafil 40mg or 80mg
A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.
干预措施: Sildenafil (Drug)
结局指标
主要结局
Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.
时间窗: Baseline and 60 minutes after drug administered
次要结局
- Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.(Baseline and 60 minutes after drug administered)
- Percent Change in Cardiac Index.(Baseline and 60 minutes after drug administered)
- Load Independent Index of Diastolic Filling.(Baseline and 60 minutes after drug administered)
- Global Longitudinal Strain(Baseline and 60 minutes after drug administered)
研究者
Brian Lindman, MD
Assistant Professor of Medicine
Washington University School of Medicine