Status:
TERMINATED
Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema
Lead Sponsor:
Washington University School of Medicine
Conditions:
Angioedema Caused by Angiotensin-Converting-Enzyme Inhibitor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 media...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older
- Must currently be on ACE inhibitor therapy and have received a dose within 36 hours
- Presenting with moderate to severe angioedema affecting the upper aerodigestive tract (face, lips, cheeks, tongue, soft palate/uvula, pharynx, and larynx). The severity of the angioedema attack will be determined by the subject's worst severity rating at baseline among 4 clinical domains (difficulty breathing, difficulty swallowing, voice changes, and tongue swelling) based on a clinically validated angioedema severity scale29 (Table)
- Presenting with ACE inhibitor-induced angioedema within 12 hours after onset
- All females must have a locally obtained negative pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy, or are two years post-menopausal do not require a pregnancy test.
- Must be able to provide written informed consent to participate in the study to fulfill all study requirements
Exclusion
- Pregnancy and/or breast feeding
- Patients with angioedema that is likely due to causes other than ACE inhibitors, including hereditary angioedema, acquired angioedema, and allergic angioedema (food, insect bite or sting with clear response to anti-allergy medications)
- Patients exhibiting acute urticaria
- Evident clinical response to glucocorticoids, antihistamines, or epinephrine
- A family history of recurrent angioedema
- Documented intolerance to plasma
- Documented congenital deficiency of immunoglobulin A in the presence of anti-immunoglobulin A antibodies
- Patients with heart failure of the severity that precludes safe transfusion of High ACE activity plasma
- Patients with acute pulmonary edema
- Patients with morbid obesity as defined by BMI\>40; morbidly obese patients have a higher volume of blood needing higher amounts of plasma and therefore will be excluded from this pilot study
- Opinion of the investigator that the patient would not be a good candidate
- Participation in a clinical study in the past 30 days
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04679311
Start Date
December 22 2020
End Date
January 31 2023
Last Update
March 27 2024
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110