Biochemical cardiac monitoring for patients initiating clozapine v 1.0
Research type
Research Study
Full title
An Investigation of Troponin T, CRP and NT-proBNP Monitoring for Patients Initiating Clozapine: A Pilot Study
IRAS ID
254589
Contact name
Kerys Thomas
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University Health Board
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
This project will investigate the possibility of establishing extra monitoring for patients within ABMU Health Board who are starting the antipsychotic clozapine, with a view to assessing whether this can identify patients at risk of potentially fatal heart- related adverse effects associated with this drug.
Schizophrenia is a chronic mental health condition, which is associated with a 2 to 3-fold increase in likelihood of early death compared to the general population (World Health Organisation (WHO), 2018).
Clozapine is an effective antipsychotic medication used to treat schizophrenia in patients for whom alternative treatments have failed. It is not used as a first-line treatment due to rare but severe (potentially life-threatening) adverse effects. These include low blood cell counts and toxic effects on the heart. All patients taking clozapine must take part in regular and routine blood testing to carefully monitor for signs of blood disorders.
Adverse effects of clozapine on the heart are less well defined and routine cardiac monitoring is not well established. There is a risk that heart problems occurring as a result of clozapine use are not fully identified and comprehensively managed effectively. Blood tests that can help to identify damage to the heart may assist in the management of patients who develop problems as a result of clozapine use.
Clozapine can only be initiated by consultant psychiatrists within the NHS. Initiation of clozapine can occur in inpatient and outpatient settings. I propose to establish pre-treatment blood tests, with repeat testing over the first month of clozapine use to investigate if this can help identify patients at risk of heart problems associated with clozapine and enable them to be referred to a cardiac specialist.
References
World Health Organisation (2018). Schizophrenia. Available at: http://www.who.int/news-room/fact-sheets/detail/schizophrenia (Accessed 11 June 2018).REC name
Wales REC 6
REC reference
19/WA/0057
Date of REC Opinion
4 Apr 2019
REC opinion
Further Information Favourable Opinion