A Phase 2 interventional study of High ACE Activity Fresh Frozen Plasma and Normal Saline in Angioedema Caused by Angiotensin-Converting-Enzyme Inhibitor, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
Angiotensin Converting Enzyme (ACE) inhibitors are among the most important and widely prescribed drugs. They reduce the morbidity and mortality associated with high blood pressure, heart disease, and kidney disease. Unfortunately, their use carries the risk of causing life-threatening airway swelling in some patients. There is currently no treatment for this condition. A novel treatment approach that may reduce or completely reverse the swelling will be tested.
The investigators will test the hypothesis that treatment with fresh frozen plasma that contains high levels of ACE activity will increase serum ACE activity and thereby cause the degradation of mediators of ACE inhibitor-induced angioedema, such as bradykinin and substance P, resulting in a shortening of the course of ACE inhibitor-induced angioedema.
16 patients with ACE inhibitor-induced angioedema will be randomized 1:1 to treatment with either 2 units of fresh frozen plasma that has been preselected for high ACE activity content (≥50 U/L) or an equal volume of normal saline. A baseline assessment of the severity of the angioedema will be performed and baseline serum levels of ACE activity will be determined. The severity of angioedema will be assessed and serum levels of ACE activity will be determined at specific intervals after each subject is treated.
69 studies on the registry are indexed under Angioedema; 16 are open to participants now.
This study's enrollment of 2 is below the median of 45 across 44 interventional studies indexed under Angioedema.
Browse Angioedema studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated with 2 units of fresh frozen plasma that have been preselected to contain ACE activity ≥50 U/L
Biological: High ACE Activity Fresh Frozen Plasma
Subjects will be treated with normal saline 500 cc.
Other: Normal Saline
Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L
Subjects will be treated with normal saline 500 cc
Determine if Treatment With 2 Units of Fresh Frozen Plasma That Contains ≥ 50 U/L of ACE Activity Increases Serum ACE Activity
The subjects' serum ACE activity will be assessed prior to treatment and 30 minutes after treatment and compared to determine if the treatment increases serum ACE activity
Time frame: Compare serum ACE activity before treatment and 30 minutes after treatment
Determine How Treatment Affects the Severity of Angioedema Using a Published Validated Clinical Rating Scale
The severity of the the subjects' angioedema will be assessed using a published validated clinical rating scale before treatment and at 30 minutes, 2 hours, and 8 hours after treatment
Time frame: Compare angioedema severity before treatment and 30 minutes, 2 hours, and 8 hours after treatment
Sustained Change in Serum ACE Activity With Treatment
Determine if treatment results in a sustained change in ACE activity levels
Time frame: Compare serum ACE activity before treatment and at 2 hours and 8 hours after treatment
| Milestone | High ACE Activity Fresh Frozen Plasma | Normal Saline |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 0 |
| Not completed | 0 | 2 |
The subjects' serum ACE activity will be assessed prior to treatment and 30 minutes after treatment and compared to determine if the treatment increases serum ACE activity
No measurements were reported for this outcome.
The severity of the the subjects' angioedema will be assessed using a published validated clinical rating scale before treatment and at 30 minutes, 2 hours, and 8 hours after treatment
No measurements were reported for this outcome.
Determine if treatment results in a sustained change in ACE activity levels
No measurements were reported for this outcome.
Collected over Patients were observed for adverse effects during their ED visit only, or up to 24 hours. No further monitoring was conducted after the patient was discharged from the ED. Both participants received placebo (normal saline).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High ACE Activity Fresh Frozen Plasma | — | — | — |
| Normal Saline | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
No patients were randomized to the High ACE FFP. Study was terminated due to end of funding period.
| Age, Categorical(Participants) | High ACE Activity Fresh Frozen Plasma | Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 2 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | High ACE Activity Fresh Frozen Plasma | Normal Saline | Total |
|---|---|---|---|
| Mean | — | 47.9 (37.1 to 58.1) | 47.9 (37.1 to 58.1) |
| Sex: Female, Male(Participants) | High ACE Activity Fresh Frozen Plasma | Normal Saline | Total |
|---|---|---|---|
| Female | — | 1 | 1 |
| Male | — | 1 | 1 |
| Race (NIH/OMB)(Participants) | High ACE Activity Fresh Frozen Plasma | Normal Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 |
| Asian | — | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 |
| Black or African American | — | 2 | 2 |
| White | — | 0 | 0 |
| More than one race | — | 0 | 0 |
| Unknown or Not Reported | — | 0 | 0 |
| Region of Enrollment(participants) | High ACE Activity Fresh Frozen Plasma | Normal Saline | Total |
|---|---|---|---|
| United States | — | 2 | 2 |
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