跳至主要内容
临床试验/EUCTR2007-002688-28-IT
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

发起方
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

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