EUCTR2007-002688-28-IT进行中(未招募)不适用
Pilot study on the short-term effects of Sildenafil on hemodynamic response to exercise and exercise capacity in Fontan patients - ND
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2007年5月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Fontan operation
- •- Stable clinical condition in the preceding 3 months
- •- Both male and female gender patients will be enrolled
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Active listing for heart transplantation
- •- Severe heart failure symptoms (NYHA functional class IV)
- •- Arterial blood saturation < 85% at rest
- •- Known liver or kidney dysfunction
- •- Lactose intolerance
- •- Hypotension (systolic blood pressure at rest < 90 mmHg)
- •- Severe arrhythmias (ventricular tachycardia or hemodynamically instable atrial arrhythmia), symptomatic hypotension (systolic blood pressure < 90 mmHg with symptoms) or severe discomfort during effort documented at a previous exercise study.
- •- Fontan operation completed during the preceding 6 months or any kind of severe illness in the preceding 3 months.
- •- Asthma or inability to exercise
- •- Pregnancy (known or suspected)
- •- Body weight <=50 Kg
研究者
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