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OpenTrials
Completed

NCT Number: NCT00449059

Nitrate and Hypertension in Heart Transplanted Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Zurich

Zurich, CH8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

acute infusion of nitroglycerine into the pulmonary artery

Drug

Primary outcomes

  1. Blood pressure reduction after acute nitroglycerine infusion

Secondary outcomes

  1. Heart rate modification after acute nitroglycerine infusion

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 19, 2007
Registry last updated
Mar 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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