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| Sponsored by: |
University of Zurich |
|---|---|
| Information provided by: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00449059 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Heart Transplantation |
Drug: acute infusion of nitroglycerine into the pulmonary artery |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Acute Effect of Nitroglycerin on Cyclosporine-Induced Hypertension After Cardiac Transplantation |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2003 |
| Study Completion Date: | December 2004 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Control group:
Exclusion criteria:
Contacts and Locations| Switzerland | |
| University Hospital of Zurich | |
| Zurich, Switzerland, CH8091 | |
| Principal Investigator: | Roberto Corti, MD | Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland |
More Information
| Study ID Numbers: | Nitrate_USZ04 |
| Study First Received: | March 15, 2007 |
| Last Updated: | March 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00449059 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
heart transplantation cyclosporine hypertension nitroglycerin |
|
Nitroglycerin Vasodilator Agents Cyclosporine Vascular Diseases |
Cardiovascular Agents Cyclosporins Hypertension |
|
Nitroglycerin Vasodilator Agents Therapeutic Uses Vascular Diseases |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions Hypertension |
