Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01574248 |
Recruitment Status :
Terminated
(DSMC recommended discontinuation for futility and feasibility)
First Posted : April 10, 2012
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ACE Inhibitor-associated Angioedema | Drug: icatibant Other: Placebo | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema - a Mulitcenter Trial |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: icatibant
30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization
|
Drug: icatibant
Subcutaneous at time 0 and 6 hours
Other Names:
|
Placebo Comparator: Placebo
Subcutaneous at time 0 and 6 hours
|
Other: Placebo
Subcutaneous at time 0 and 6 hours |
- Time to Resolution of Angioedema [ Time Frame: 48 hours ]Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.
- Number of Participants With Admission to Intensive Care Unit [ Time Frame: T0 to T48 hours ]
- Number of Participants With Requirement for Intubation [ Time Frame: T0 to T48 hours ]
- Number of Participants Given Steroids [ Time Frame: T0 to T48 hours ]
- Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers [ Time Frame: T0 to T48 hours ]
- Number of Participants Given Epinephrine [ Time Frame: T0 to T48 hours ]
- Systolic Blood Pressure [ Time Frame: T0 to T48 hours ]Average of blood pressure measurements from zero to forty-eight hours provided.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574248
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37235 |
Principal Investigator: | Nancy J. Brown, MD | Vanderbilt University |
Responsible Party: | Nancy J. Brown, Chair Department of Medicine, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT01574248 |
Other Study ID Numbers: |
000626 |
First Posted: | April 10, 2012 Key Record Dates |
Results First Posted: | February 17, 2017 |
Last Update Posted: | February 17, 2017 |
Last Verified: | December 2016 |
ACE inhibitor Angioedema Bradykinin Swelling |
Angioedema Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Icatibant Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Bradykinin B2 Receptor Antagonists Bradykinin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors |