Nitrate and Hypertension in Heart Transplanted Patients

March 15, 2007 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH8091
        • University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood pressure reduction after acute nitroglycerine infusion

Secondary Outcome Measures

Outcome Measure
Heart rate modification after acute nitroglycerine infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Roberto Corti, MD, Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2007

Last Update Submitted That Met QC Criteria

March 15, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nitrate_USZ04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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