Nitrate and Hypertension in Heart Transplanted Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

March 15, 2007

Last Updated Date

March 15, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Blood pressure reduction after acute nitroglycerine infusion

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Heart rate modification after acute nitroglycerine infusion

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Nitrate and Hypertension in Heart Transplanted Patients

Official Title ^ICMJE

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

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 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension
Heart Transplantation

Intervention ^ICMJE

Drug: acute infusion of nitroglycerine into the pulmonary artery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00449059

Responsible Party

Study ID Numbers ^ICMJE

Nitrate_USZ04

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roberto Corti, MD

Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

Information Provided By

University of Zurich

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP