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临床试验/EUCTR2010-024175-58-CZ
EUCTR2010-024175-58-CZ进行中(未招募)1 期

Comparison of two treatment options for hypertension in heart transplant recipients

IKEM0 个研究点目标入组 40 人开始时间: 2011年4月13日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
IKEM
入组人数
40

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

  • Patients aged between 18-65 years ,who are undergoing heart transplantation, and who develop hypertension during the first 6 months, which will require treatment
  • 2) A patient who understands the purpose of the study, which was fully informed and gave written consent to participate in the study
  • 3) blood pressure> 130/80 mmHg
  • 4) The value of serum potassium <5 mmol / l
  • 5) Serum creatinine lower or equal than 150 micromol / l glomerular filtration rate > 1.0 ml / s
  • 6) No serious complications associated with surgery (graft failure ,hemodynamic instability, severe acute rejection, renal failure)
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1) Patient after heart transplantation more than 6 months
  • 2) The presence of serious complications after heart transplantation (graft failure,
  • hemodynamic instability, severe acute rejection)
  • 3) Hyperkalemia (serum potassium concentration> 5.3 mmol / l)
  • 4) Current use of potassium-sparing diuretics
  • 5) Patients with significant renal impairment defined as an increase creatinine higher or equal to 250 umol/l
  • 6) Patients with significantly elevated liver function tests (defined as AST and ALT
  • increased to three times the normal values
  • 7) Anemia (hemoglobin <90 g / l)
  • 8) Retransplantation or multiorgan transplantation
  • 9) Women who are unable or unwilling to use two barrier contraception
  • 10) Pregnant women or nursing mothers
  • 11) Inability to take oral medication
  • 12) Patients unable to give informed consent
  • 13) Patients with mental disorder or condition, which in the opinion investigator might
  • compromise communication with the investigator
  • 14). Participation of patients in another clinical trial during the last 30 days
  • 15). Patients with known sensitivity (sensitivity) of perindopril or losartan
  • or a chemically related components

研究者

发起方
IKEM

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