ACE Inhibitor-associated Angioedema Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment