Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000934943
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
18/09/2020
Date last updated
18/09/2020
Date data sharing statement initially provided
18/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Quinidine therapy in Brugada Syndrome
Scientific title
Investigating non-invasive markers to determine the effect of quinidine treatment in patients with Brugada Syndrome.
Secondary ID [1] 302098 0
None
Universal Trial Number (UTN)
Trial acronym
QUIET BrS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brugada Syndrome 317825 0
Condition category
Condition code
Cardiovascular 315884 315884 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hydroquinidine 300mg, oral capsule, twice daily
For 2 weeks
Adherence will be monitored by patient report and tablet return. Serum quinidine levels will also be performed.
This is a non-randomised trial.
Intervention code [1] 317797 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324228 0
Epicardial activation time by ECGi
Timepoint [1] 324228 0
Following 14+/- 7 days of quinidine therapy.
Primary outcome [2] 324868 0
Epicardial recovery time by ECGi
Timepoint [2] 324868 0
Following 14+/- 7 days of quinidine therapy.
Primary outcome [3] 324869 0
Temporal burden of type 1 Brugada pattern ECG on 12-lead Holter
Timepoint [3] 324869 0
Following 14+/- 7 days of quinidine therapy.
Secondary outcome [1] 384120 0
Reported tolerability of quinidine therapy as assessed by medication questionnaire (designed for this study) and self-reported adverse events.
Timepoint [1] 384120 0
Following 14+/- 7 days of quinidine therapy.

Eligibility
Key inclusion criteria
Diagnosis of Brugada Syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treatment with drug known to prolong QT interval
Baseline QTc >450msec for men, > 460msec for women
Baseline QRS > 130msec
Baseline PR >200msec
Patients taking medications known to interact with quinidine
Known hypersensitivity to quinidine

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
This is an open-label, exploratory pilot study looking to compare electrophysiological characteristics on and off quinidine. Being an exploratory pilot study, this protocol does not have predetermined endpoints but is rather designed to assess the utility of multiple non-invasive parameters and their feasibility for use in future trials. The results of this initial pilot study may inform the magnitude of effect and provide data for power calculations in future clinical trials of Quinidine therapy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2020
Actual
Date of last participant enrolment
Anticipated
5/04/2021
Actual
Date of last data collection
Anticipated
5/07/2021
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16860 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 30509 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 305933 0
Charities/Societies/Foundations
Name [1] 305933 0
Heart Foundation of Australia
Country [1] 305933 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 306502 0
None
Name [1] 306502 0
Address [1] 306502 0
Country [1] 306502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306180 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306180 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 306180 0
Australia
Date submitted for ethics approval [1] 306180 0
01/07/2019
Approval date [1] 306180 0
28/05/2020
Ethics approval number [1] 306180 0

Summary
Brief summary
Quinidine is the only drug shown to reduce the risk of dangerous irregular heart rhythms in Brugada Syndrome. While studies have shown invasive electrophysiology studies can be useful in assessing response to quinidine in Brugada Syndrome, currently, there is no definitive way to monitor drug effect in an individual. The QUIET BrS Study will investigate the effect of quinidine on a variety of clinical parameters in patients with Brugada syndrome. We seek to identify non-invasive markers of quinidine effect in patients with Brugada Syndrome which could be used to develop a non-invasive strategy for monitoring medical therapy in these patients and reduce the need for invasive procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102990 0
A/Prof Raymond Sy
Address 102990 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country 102990 0
Australia
Phone 102990 0
+61 2 9515 8063
Fax 102990 0
Email 102990 0
[email protected]
Contact person for public queries
Name 102991 0
Dr Julia Isbister
Address 102991 0
Agnes Ginges Centre for Molecular Cardiology
Centernary Institute
Building 93, RPAH grounds,
John Hopkins Dr,
CAMPERDOWN NSW 2050
Country 102991 0
Australia
Phone 102991 0
+61 2 9565 6187
Fax 102991 0
Email 102991 0
[email protected]
Contact person for scientific queries
Name 102992 0
Dr Julia Isbister
Address 102992 0
Agnes Ginges Centre for Molecular Cardiology
Centernary Institute
Building 93, RPAH grounds,
John Hopkins Dr,
CAMPERDOWN NSW 2050
Country 102992 0
Australia
Phone 102992 0
+61 2 9565 6187
Fax 102992 0
Email 102992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.