Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cardiac Index
研究概览
简要总结
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).
详细描述
Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. Right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Treatment was blinded by the institutional pharmacy embedding the placebo or treatment pill in a gelatinous cap
入排标准
- 年龄范围
- 80 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (CT)
- •symptom duration of less than 14 days
- •older than 18-80 years
- •right ventricular/left ventricular ratio (RV/LV) >1 measured by trans-thoracic echocardiography (TTE, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole).
排除标准
- •cardiac arrest that required cardiopulmonary resuscitation
- •a life expectancy <120 days
- •systolic blood pressure <90 mmHg
- •metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (CMR)
- •altered mental status making the patient unable to provide informed consent
- •recent use of drugs with influence on the Nitric oxide-cyclic guanosine monophosphate pathway
- •known or suspected chronic thromboembolic pulmonary hypertension
- •inability to perform study protocol < 72 hours after conventional PE treatment was instituted
- •active bleeding after thrombolysis.
研究组 & 干预措施
Sildenafil
50 mg sildenafil oral. One dose
干预措施: Sildenafil (Drug)
Placebo
Placebo pill. One dose
干预措施: Placebo (Drug)
结局指标
主要结局
Cardiac Index
时间窗: 74 (plus/minus 17) minutes after drug administration
Cardiac Index measured by cardiac magnetic resonance imaging
次要结局
未报告次要终点