Angioedema Caused by Angiotensin-Converting-Enzyme Inhibitor Clinical Trial
Official title:
High Angiotensin Converting Enzyme Activity-containing Plasma for the Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema
| Verified date | February 2024 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | January 31, 2023 |
| Est. primary completion date | January 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine |
United States,
Chen SX, Hermelin D, Weintraub SJ. Possible donor-dependent differences in efficacy of fresh frozen plasma for treatment of ACE inhibitor-induced angioedema. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):2087-2088. doi: 10.1016/j.jaip.2019.02.027. Epub 2019 Mar 2. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Compare serum ACE activity before treatment and 30 minutes after treatment | |
| Secondary | 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 | Compare angioedema severity before treatment and 30 minutes, 2 hours, and 8 hours after treatment | |
| Secondary | Sustained Change in Serum ACE Activity With Treatment | Determine if treatment results in a sustained change in ACE activity levels | Compare serum ACE activity before treatment and at 2 hours and 8 hours after treatment |