Angiotensin Converting Enzyme (ACE) inhibitors are among the most important and widely prescribed drugs. They reduce the morbidity and mortality associated with high blood pressure, heart disease, and kidney disease. Unfortunately, their use carries the risk of causing life-threatening airway swelling in some patients. There is currently no treatment for this condition. A novel treatment approach that may reduce or completely reverse the swelling will be tested.
The investigators will test the hypothesis that treatment with fresh frozen plasma that contains high levels of ACE activity will increase serum ACE activity and thereby cause the degradation of mediators of ACE inhibitor-induced angioedema, such as bradykinin and substance P, resulting in a shortening of the course of ACE inhibitor-induced angioedema. 16 patients with ACE inhibitor-induced angioedema will be randomized 1:1 to treatment with either 2 units of fresh frozen plasma that has been preselected for high ACE activity content (≥50 U/L) or an equal volume of normal saline. A baseline assessment of the severity of the angioedema will be performed and baseline serum levels of ACE activity will be determined. The severity of angioedema will be assessed and serum levels of ACE activity will be determined at specific intervals after each subject is treated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L
Subjects will be treated with normal saline 500 cc
Barnes-Jewish Hospital
St Louis, Missouri, United States
Determine if Treatment With 2 Units of Fresh Frozen Plasma That Contains ≥ 50 U/L of ACE Activity Increases Serum ACE Activity
The subjects' serum ACE activity will be assessed prior to treatment and 30 minutes after treatment and compared to determine if the treatment increases serum ACE activity
Time frame: Compare serum ACE activity before treatment and 30 minutes after treatment
Determine How Treatment Affects the Severity of Angioedema Using a Published Validated Clinical Rating Scale
The severity of the the subjects' angioedema will be assessed using a published validated clinical rating scale before treatment and at 30 minutes, 2 hours, and 8 hours after treatment
Time frame: Compare angioedema severity before treatment and 30 minutes, 2 hours, and 8 hours after treatment
Sustained Change in Serum ACE Activity With Treatment
Determine if treatment results in a sustained change in ACE activity levels
Time frame: Compare serum ACE activity before treatment and at 2 hours and 8 hours after treatment
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