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临床试验/NCT00449059
NCT00449059已完成4 期

Acute Effect of Nitroglycerin on Cyclosporine-Induced Hypertension After Cardiac Transplantation

University of Zurich2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Blood pressure reduction after acute nitroglycerine infusion

研究概览

简要总结

The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood pressure and heart rate in heart-transplanted patients with cyclosporine-induced hypertension.

详细描述

Background: Cyclosporine represents a milestone in immunosuppression after organ transplantation. Its use, however, comes at the cost of significant side effects, such as arterial hypertension. Our aim was to investigate the effect of acute administration of nitroglycerin in heart-transplanted patients with cyclosporine-induced hypertension.

Methods: We included 18 hypertensive patients (HT) scheduled for elective cardiac catheterization after heart transplantation and treated with cyclosporine, as well as 6-matched HT. Simultaneous measurements of BP in the aorta and pulmonary artery before and after administration of nitroglycerin were done.

Results: After injection of 50μg and 100μg nitroglycerin a significant BP decrease was observed both in heart-transplanted patients (sBP p=0.0001; dBP p=0.0001) and in controls (sBP p=0.006; dBP p=0.05). This reduction was more pronounced in heart-transplanted patients (sBP p=0.022; dBP 0.018 for group comparison). 8±3 minutes after the last nitrate infusion BP remained significantly reduced vs baseline in heart-transplanted patients (p<0.001) while it comes back to baseline in controls. The reduction in sBP (p=0.04 after 50μg nitroglycerin; p=0.05 after 100μg nitroglycerin) but not dBP correlated to cyclosporinemia.

Conclusions: This study indicates that nitroglycerin reduces sBP in heart-transplanted patients with cyclosporine-induced hypertension. Further studies are needed to evaluate the long-term effect of nitrates in these patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Heart-transplanted group:
  • Patients with hypertension and treated with cyclosporine
  • Patients under optimal standard therapy
  • Patients giving written informed consent
  • Control group:
  • Patients with hypertension
  • Patients without prior transplantation of any kind
  • Patients giving written informed consent
  • Exclusion criteria:
  • Hypertensive patients receiving immunosuppressive drugs
  • Patients receiving any kind or nitrate derivates

排除标准

  • 未提供

结局指标

主要结局

Blood pressure reduction after acute nitroglycerine infusion

次要结局

  • Heart rate modification after acute nitroglycerine infusion

研究者

申办方类型
Other

研究点 (2)

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