跳至主要内容
临床试验/EUCTR2007-004150-85-DE
EUCTR2007-004150-85-DE进行中(未招募)不适用

Cardiac failure with normal ejection fraction: possible role of phosphodiesterase type 5 inhibitors - HINEF: PDE5

Charité Universitaetsmedizin Berlin0 个研究点开始时间: 2007年12月4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

  • - accomplished patient information, and written informed consent of the patient
  • - age between 18 and 75
  • - at least 1 admission to the hospital with diagnosis cardiac insufficiency NYHA class II-IV in the past
  • - negative pregnancy test
  • - women of childbearing age only with highly effective contraception (defined as
  • PEARL-Index < 1 %)
  • - no participation in another driven study according to german drugs act (30 days before and during the trial)
  • - sufficient renal function (creatinin under 1,7 mg/dl)
  • - sufficient hepatic function (serum GOT, serum GPT under 60 U/l)
  • 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

  • - pregnancy and lactation
  • - women of childbearing age without highly effective contraception
  • - coronary heart disease with significant stenosis after implantation of a coronary stent
  • - cardiac valve diseases higher than class I (aortic, mitral and tricuspidic)
  • - hypersensitivity to contrast substance
  • - acute apoplexy
  • - arterial hypotension (below 90/50 of Hg)
  • - neoplasmatic diseases with expected survival < 18 months
  • - nonarteritic anterior ischemic optic neuropathy (NAION)
  • - simultaneous taking of No donators, alpha blockers and/or other PDE-5 inhibitors (Viagra, Cialis)
  • - hepatic insufficiency (CHILD PHUG C)
  • - renal insufficiency requiring dialysis
  • - cardiac infarction or apoplexis during the last 6 months
  • - retinitis pigmentosa
  • - simultaneous taking of itraconazole/ketoconazole
  • - HIV infection and/or taking of HIV protease inhibitors
  • - active hepatitis A/B
  • - hypersensitivity against vardenafil
  • - Persons who are detained officially or legally to an official institute (e.g. psychiatric
  • institute or prison)
  • - missing willingness to storaging and transferring pseudonymous disease data within this study
  • - missing willingness to cooperate

研究者

发起方
Charité Universitaetsmedizin Berlin

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