Viewing Study NCT00449059



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Study NCT ID: NCT00449059
Status: COMPLETED
Last Update Posted: 2007-03-19
First Post: 2007-03-15

Brief Title: Nitrate and Hypertension in Heart Transplanted Patients
Sponsor: University of Zurich
Organization: University of Zurich

Study Overview

Official Title: Acute Effect of Nitroglycerin on Cyclosporine-Induced Hypertension After Cardiac Transplantation
Status: COMPLETED
Status Verified Date: 2007-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 p00001 dBP p00001 and in controls sBP p0006 dBP p005 This reduction was more pronounced in heart-transplanted patients sBP p0022 dBP 0018 for group comparison 83 minutes after the last nitrate infusion BP remained significantly reduced vs baseline in heart-transplanted patients p0001 while it comes back to baseline in controls The reduction in sBP p004 after 50μg nitroglycerin p005 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None