The Cardiac Complications Of Clozapine Study

Not Applicable

• Conditions: Schizophrenia / schizoaffective disorder patients on clozapine medical therapy; Mental Health - Schizophrenia

• Registration Number: ACTRN12607000199415
• Lead Sponsor: Department of Cardiology, Eastern Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of echocardiographic and/or electrocardiographic abnormalities of the myocardium[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 ];Change in circulating marker of myocardial damage (troponin I or T)[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 ];Change in circulating marker of myocardial stretch (NT-BNP)[Weeks 4 and 24 following clozapine initiation]

Secondary Outcome Measures

Name	Time	Method
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.[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.]