Nitrate and Hypertension in Heart Transplanted Patients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449059
• Other study ID #: Nitrate_USZ04
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2007
• Last updated: March 15, 2007
• Start date: January 2003
• Est. completion date: December 2004

Study information

• Verified date: March 2007
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation
• Hypertension

Intervention

Drug:
• acute infusion of nitroglycerine into the pulmonary artery

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure reduction after acute nitroglycerine infusion
Secondary	Heart rate modification after acute nitroglycerine infusion