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Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

Descriptive Information
Brief Title † Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema
Official Title † Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema - a Mulitcenter Trial
Brief Summary Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.
Detailed Description People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet. In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty. ACE inhibitors prevent the breakdown of a natural chemical in the body called bradykinin. Increased levels of bradykinin, which can cause swelling, may contribute to the development of angioedema. Blocking bradykinin receptor cells prevents bradykinin from initiating swelling and may lead to a possible decrease in angioedema symptoms. The purpose of this study is to evaluate the effectiveness of HOE-140, a bradykinin receptor blocker, at reducing symptoms in people with ACE inhibitor-associated angioedema. This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema. Participants will be randomly assigned to receive an injection of either HOE-140 or placebo. Initially, participants will undergo an electrocardiogram to measure the electrical activity of the heart. Then blood pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit that will occur 7 days after the resolution of angioedema symptoms.
Study Phase Phase 0
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary Outcome Measure † Time to resolution of angioedema
Secondary Outcome Measure † Length of hospital stay
Condition † ACE Inhibitor-associated Angioedema
Intervention † Drugicatibant
Study Arms / Comparison Groups icatibant 30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization Placebo Subcutaneous at time 0 and 6 hours
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 32
Start Date † August 2011
Completion Date
Primary Completion Date June 2016
Eligibility Criteria † Inclusion Criteria: - The subject has ongoing angioedema while taking an ACE inhibitor. - The subject is between 18 and 80 years of age. Exclusion Criteria: - The subject has had angioedema while not taking an ACE inhibitor. - The subject's angioedema only involves the bowel. - The subject is known to be pregnant or has a positive urine pregnancy test. - The subject has started on an oral contraceptive within the last 6 months.
Gender Both
Ages 18 Years - 80 Years
Accepts Healthy Volunteers No
Contacts †† Nancy J Brown, MD, 615-343-8701, nancy.j.brown@vanderbilt.edu
Location Countries † United States
Administrative Information
NCT ID † NCT01574248
Organization ID 000626
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Vanderbilt University
Collaborators †† University of California, San Diego
Investigators † Principal Investigator: Nancy J. Brown, MD, Vanderbilt University
Information Provided By
Verification Date July 2015
First Received Date † December 14, 2011
Last Updated Date July 8, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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