Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00517582 |
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.
Condition | Intervention | Phase |
---|---|---|
Angioneurotic Edema |
Drug: HOE-140 Other: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study of a Bradykinin Receptor Blocker in Angiotensin Converting Enzyme Inhibitor-Associated Angioedema |
Estimated Enrollment: | 24 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
HOE-140: Experimental |
Drug: HOE-140
Subcutaneous at time 0 and 6 hours
|
Placebo: Placebo Comparator |
Other: Placebo
Subcutaneous at time 0 and 6 hours
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nancy J. Brown, MD | 615-343-8701 | nancy.j.brown@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37205 | |
Contact: Nancy J Brown, MD 615-343-8701 | |
Contact: Libby Stone, RN 615-343-8701 |
Principal Investigator: | Nancy J. Brown, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Nancy J. Brown, MD ) |
Study ID Numbers: | 495, HL079184-Specific Aim 1 |
Study First Received: | August 15, 2007 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00517582 |
Health Authority: | United States: Food and Drug Administration |
ACE Inhibitor Angioedema Bradykinin Swelling |
Hypersensitivity Bradykinin Skin Diseases Angioedema Hypersensitivity, Immediate |
Vascular Diseases Edema Urticaria Icatibant |
Vasodilator Agents Skin Diseases, Vascular Immune System Diseases Therapeutic Uses |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |