Nitrate and Hypertension in Heart Transplanted Patients
Information source: University of Zurich
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Heart Transplantation
Intervention: acute infusion of nitroglycerine into the pulmonary artery (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Zurich Official(s) and/or principal investigator(s):
Roberto Corti, MD, Principal Investigator, Affiliation: Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
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.
Clinical Details
Official title: Acute Effect of Nitroglycerin on Cyclosporine-Induced Hypertension After Cardiac Transplantation
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Blood pressure reduction after acute nitroglycerine infusion
Secondary outcome: Heart rate modification after acute nitroglycerine infusion
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital of Zurich, Zurich CH8091, Switzerland
Additional Information
Starting date: January 2003
Ending date: December 2004
Last updated: March 15, 2007
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