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临床试验/EUCTR2013-001659-10-BE
EUCTR2013-001659-10-BE进行中(未招募)不适用

Acute effects of Sildenafil on the hemodynamics, Right Ventricle performance and cyclic GMP concentration in Heart failure patients with preserved left ventricular ejection fraction and patients after heart transplantation (SIRVEH study) - SIRVEH study

ZLeuven0 个研究点开始时间: 2013年5月21日最近更新:
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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

  • -Have LVEF > 45%
  • -During last 12 months
  • oWere hospitalized for heart decompensation and/or needed IV diuretics use
  • oWere catheterized for dyspnea and presented with PCWP > 15 mmHg and/or LVEDP > 18 mmHg
  • oAre on the chronic diuretics treatment and on the echocardiography have:
  • ?E/E’ > 15
  • ?8 < E/E’ < 15 and
  • E/A < 0.5 and DT> 280 ms OR
  • Ard-Ad > 30 msOR
  • LAVI > 40 ml/m²OR
  • LVMI > 122 g/m² (F) or > 149 g/m² (M) OR
  • NT-ProBNP> 400 pg/ml
  • For heart transplant patients
  • HTX patients with dyspnea and/or chronic diuretics treatment who
  • -Have LVEF > 45%
  • -During last 12 months presented with PCWP > 15 mmHg and/or LVEDP > 18 mmHg on the right heart catheterization (RHC)
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • -Patients under 18 years of age
  • -Pregnancy
  • -Patients with severe valvular insufficiencies en stenosis
  • -Patients with the history of left ventricular dysfunction with LVEF< 45%

研究者

发起方
ZLeuven

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