Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000199415
Ethics application status
Not yet submitted
Date submitted
4/04/2007
Date registered
12/04/2007
Date last updated
12/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Cardiac Complications Of Clozapine Study
Scientific title
Identifying Early Subtle Changes In Cardiac Function That Precede Overt Dysfunction In Schizophrenic Patients Taking Clozapine
Universal Trial Number (UTN)
Trial acronym
CCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia / schizoaffective disorder patients on clozapine medical therapy 1723 0
Condition category
Condition code
Mental Health 1814 1814 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An ongoing observational study over clozapine treatment duration. Clozapine is used to treat patients with schizophrenia who do not respond to commonly used antipsychotic medicines. Clozapine has proved to be very effective and has been shown to reduce the high rate of suicide in these patients. While generally temporary and not life-threatening, a few side effects can be fatal. In particular, inflammation and reduced contraction (dysfunction) of the heart muscle have been documented with clozapine use. This study will attempt to identify early subtle changes in heart function that precede overt dysfunction in patients taking clozapine. Such patients displaying early signs during can then be identified and managed appropriately. The study is for the duration of the participants receiving Clozapine treatment until the treatment is ceased due to patient non-compliance, adverse effect, death, or other at the discretion of the treating physician.
Intervention code [1] 1690 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2535 0
Development of echocardiographic and/or electrocardiographic abnormalities of the myocardium
Timepoint [1] 2535 0
Weeks 1, 2, 3, 4, 24 and 52, and every 6 months thereafter following clozapine initiation, until treatment is ceased due to patient non-compliance, adverse effect, death, or other at the discretion of the treating physician
Primary outcome [2] 2536 0
Change in circulating marker of myocardial damage (troponin I or T)
Timepoint [2] 2536 0
Weeks 1, 2, 3, 4, 24 and 52, and every 6 months thereafter following clozapine initiation, until treatment is ceased due to patient non-compliance, adverse effect, death, or other at the discretion of the treating physician
Primary outcome [3] 2537 0
Change in circulating marker of myocardial stretch (NT-BNP)
Timepoint [3] 2537 0
Weeks 4 and 24 following clozapine initiation
Secondary outcome [1] 4386 0
Correlation of primary outcome measures with clinical events, in particular, deterioration in clinical status or the development of asymptomatic left ventricular dysfunction, myocarditis or cardiomyopathy.
Timepoint [1] 4386 0
Weeks 1, 2, 3, 4, 24 and 52, and every 6 months thereafter following Clozapine initiation, until treatment is ceased due to patient non-compliance, adverse effect, death, or other at the discretion of the treating physician.

Eligibility
Key inclusion criteria
All patients with schizophrenia or schizoaffective disorder who are commencing clozapine therapy as inpatients or outpatients through the Eastern Health Adult Mental Health Program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of cardiac disease including heart failure, ischemic heart disease, cardiomyopathy and hemochromatosis.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1966 0
Government body
Name [1] 1966 0
Eastern Health
Country [1] 1966 0
Australia
Funding source category [2] 1967 0
University
Name [2] 1967 0
Monash University
Country [2] 1967 0
Australia
Primary sponsor type
Hospital
Name
Department of Cardiology, Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 1778 0
Hospital
Name [1] 1778 0
Department of Psychiatry, Eastern Health
Address [1] 1778 0
Country [1] 1778 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3661 0
Eastern Health Adult Mental Health Committee
Ethics committee address [1] 3661 0
Ethics committee country [1] 3661 0
Australia
Date submitted for ethics approval [1] 3661 0
Approval date [1] 3661 0
Ethics approval number [1] 3661 0
Ethics committee name [2] 3662 0
Eastern Health Ethics Committee
Ethics committee address [2] 3662 0
Ethics committee country [2] 3662 0
Australia
Date submitted for ethics approval [2] 3662 0
Approval date [2] 3662 0
Ethics approval number [2] 3662 0

Summary
Brief summary
Almost one third of patients with schizophrenia do not respond to commonly used antipsychotic medicines. For up to 60% of these patients, the novel antipsychotic medicine clozapine can be very effective and has been shown to reduce the high rate of suicide in these patients. While generally temporary and not life-threatening, a few side effects can be fatal. In particular, inflammation and reduced contraction (dysfunction) of the heart muscle have been documented with clozapine use (up to 8.5% of patients). The cause of the heart problems following clozapine use is not known, and there is a need to identify patients at greater risk of developing these side effects during treatment.

The current study will observe about 40 adult patients each year with schizophrenia starting clozapine therapy through the Eastern Health Adult Mental Health Program. As is standard care for this group of patients, assessments of heart function will be performed prior to, and at regular intervals from 1 to 6 months, and each 6 months thereafter, for the duration of treatment. We hypothesise that this study will identify early subtle changes in heart function that precede overt dysfunction in patients taking clozapine. Such patients displaying early signs during can then be identified and managed appropriately.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27793 0
Address 27793 0
Country 27793 0
Phone 27793 0
Fax 27793 0
Email 27793 0
Contact person for public queries
Name 10879 0
Dr Louise Roberts
Address 10879 0
4th Floor
Clive Ward Building
16 Arnold Street
Box Hill VIC 3128
Country 10879 0
Australia
Phone 10879 0
+61 3 88923662
Fax 10879 0
+61 3 88923659
Email 10879 0
[email protected]
Contact person for scientific queries
Name 1807 0
Dr Rachel Denver
Address 1807 0
Department of Cardiology
Box Hill Hospital
Level 2
Nelson Road
Box Hill VIC 3128
Country 1807 0
Australia
Phone 1807 0
+61 3 98954830
Fax 1807 0
+61 3 98954834
Email 1807 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.