Nitrate and Hypertension in Heart Transplanted Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Heart Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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acute infusion of nitroglycerine into the pulmonary artery

Intervention Type DRUG

Eligibility Criteria

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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