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The Cardiac Complications Of Clozapine Study

Identifying Early Subtle Changes In Cardiac Function That Precede Overt Dysfunction In Schizophrenic Patients Taking Clozapine

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12607000199415
Acronym
CCC
Enrollment
120
Registered
2007-04-12
Start date
2007-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 clozap

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.

Sponsors

Department of Cardiology, Eastern Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Previous history of cardiac disease including heart failure, ischemic heart disease, cardiomyopathy and hemochromatosis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026