MedTrace Logo

Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema

NCT04679311 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-03-27

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Angioedema Caused by Angiotensin-Converting-Enzyme Inhibitor

Interventions

BIOLOGICAL

High ACE Activity Fresh Frozen Plasma

Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L

OTHER

Normal Saline

Subjects will be treated with normal saline 500 cc

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Steven J Weintraub, M.D. · Washington University School of Medicine and the St. Louis VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679311 on ClinicalTrials.gov