Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000188932
Ethics application status
Not yet submitted
Date submitted
15/02/2011
Date registered
17/02/2011
Date last updated
9/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Genetic markers for ACE inhibitor associated angioedema
Scientific title
Genetic analysis for C-2399A polymorphism of the XPNPEP2 gene in patients who have had ACE inhibitor associated angioedema compared to those without and healthy population control subjects - an observational study.
Secondary ID [1] 253450 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
GMAAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Angioedema - ACE inhibitor associated 261001 0
Condition category
Condition code
Inflammatory and Immune System 259136 259136 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study subjects will have had an episode of ACE inhibitor angioedema. This may have occured at some time in the past from 2005 to the present, or in the future. Cases will be identified from the Immunology Clinic at the Royal Adelaide Hospital, and private clinics of immunologists working at the RAH. Cases will be collected prospectively until a total of approximately 40 have been collected. Buccal cheek swabs will be used to obtain material for genetic analysis. Genetic analysis will be conducted to determine the frequency of occurrence of the C-2399A SNP of the XPNPEP2 gene. These cases will be compared with a control group, who have not had ACE inhibitor associated angioedema, who will be collected prospectively 2010 and ongoing. This is a genetic study, so samples will be collected at a single point in time. Individual patients will not be observed over a period of time.
Intervention code [1] 257892 0
Not applicable
Comparator / control treatment
Frequency of occurrence of the C-2399A SNP will also be calculated in a group of patients who have been exposed to ACE inhibitors, but who have not had ACE inhibitor angioedema. These patients will be collected prospectively. A sample for genetic analysis will be taken at a single point in time, so individual patients will not be followed over time.
Comparison will also be made with population samples, from healthy population, available in an existing DNA bank. These samples have already been collected.
Control group
Active

Outcomes
Primary outcome [1] 261988 0
frequency of single nucleotide polymorphism C-2339A of XPNPEP2 gene
Timepoint [1] 261988 0
This is a genetic study, looking a genetic variants between the study groups. As such, the outcome for each patient will only be measured once in the course of the study, as it is not expected that the genetic findings will vary over time.
Secondary outcome [1] 268920 0
nil
Timepoint [1] 268920 0
nil

Eligibility
Key inclusion criteria
patients with a history of ACE inhibitor associated angioedema
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
angioedema due to other pathology ie C1 esterase inhibitor defiency, food or other drug allergy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258368 0
Self funded/Unfunded
Name [1] 258368 0
Country [1] 258368 0
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 257513 0
University
Name [1] 257513 0
University of Adelaide
Address [1] 257513 0
Department of Clinical and Experimental Pharmacology
North Terrace
Adelaide 5000
Country [1] 257513 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260336 0
Ethics committee address [1] 260336 0
Ethics committee country [1] 260336 0
Date submitted for ethics approval [1] 260336 0
10/02/2011
Approval date [1] 260336 0
Ethics approval number [1] 260336 0

Summary
Brief summary
ACE inhibitors are a widely prescribed class of medications in Australia with established benefits in reducing mortality in a range of cardiovascular, endocrine and renal conditions. They are generally well tolerated in many patients, although they are assoicated with a range of adverse effects. One of these adverse effects is angioedema, which usually presents as non-pitting oedema of the subcutaneous tissues, usually around the head and neck. Occassionally airway obstruction may occur. While there are some recognised risk factors for ACE inhibitor associated angioedema, it is not possible to prospectively identify patients at particular risk. Improved methods to identify patients at risk may be useful to improve drug safety. One small study has identified a genetic marker, the single-nucleotide polymorphism, C-2399A of the XPNPEP2 gene which encodes plasma aminopeptidase P, for increased risk of ACE inhibitor associated angioedema. This study attempts to confirm the previous study and investigate the frequency of this genetic variant in the Australian population. We aim to enroll 40 patients who have had an episode of ACE inhibitor associated angioedema, and compare the frequency of the genetic variant in these patients with 120 control patients who have been exposed to ACE inhibitor, but have not had angioedema. We will also compare the frequency in a population sample, from healthy people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32117 0
Address 32117 0
Country 32117 0
Phone 32117 0
Fax 32117 0
Email 32117 0
Contact person for public queries
Name 15364 0
Dr Genevieve Gabb
Address 15364 0
VMO Office, Level 8 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia
Country 15364 0
Australia
Phone 15364 0
+61 8 82224613
Fax 15364 0
+61 8 82225900
Email 15364 0
[email protected]
Contact person for scientific queries
Name 6292 0
Professor Andrew Somogyi
Address 6292 0
Discipline of Pharmacology
The University of Adelaide
North Terrace
Adelaide 5000
South Australia
Country 6292 0
Australia
Phone 6292 0
+61 8 83035572
Fax 6292 0
Email 6292 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.