ANZCTR - Registration

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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]

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

Condition category

Condition code

Inflammatory and Immune System

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]

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]

frequency of single nucleotide polymorphism C-2339A of XPNPEP2 gene

Timepoint [1]

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]

nil

Timepoint [1]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

North Terrace
Adelaide 5000
South Australia

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Adelaide

Address [1]

Department of Clinical and Experimental Pharmacology
North Terrace
Adelaide 5000

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

10/02/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Genevieve Gabb

Address

VMO Office, Level 8 North Wing
Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia

Country

Australia

Phone

+61 8 82224613

Fax

+61 8 82225900

genevieve.gabb@health.sa.gov.au

Contact person for scientific queries

Name

Professor Andrew Somogyi

Address

Discipline of Pharmacology
The University of Adelaide
North Terrace
Adelaide 5000
South Australia

Country

Australia

Phone

+61 8 83035572

Fax

andrew.somogyi@adelaide.edu.au

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.

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