Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema
| Status: | Terminated |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | February 2016 |
Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema - a Mulitcenter Trial
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.
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.
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.
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.
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.
We found this trial at
2
sites
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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