Effects of Lurasidone on Left Ventricle Systolic Functions (Lurasidone)

Evaluation of Left Ventricle Systolic Functions of Patients On Lurasidone

The goal of our study to learn if lurasidone molecule which is used on patients with schizophrenia or bipolar disorder has any cardiotoxic effect.

Study Overview

• Status: Not yet recruiting
• Conditions: Bipolar Disorders; Schizophrenia Patients; Lurasidone Cardiotoxicity
• Intervention / Treatment: Diagnostic test: Global Longitudinal Strain

Detailed Description

Lurasidone is an atypical antipsychotic drug used both on patients with schizophrenia or bipolar disorder. It improves patients' clinical symptoms through dopamine D2 and serotonin 5-HT2A receptor antagonism. However, the effect of antipsychotic drugs on cardiac functions is an important parameter for patient safety during the treatment process. Although the existing literature on the cardiac effects of lurasidone is limited, atypical antipsychotic are known to cause corrected QT interval prolongation, arrhythmias and suppression on cardiac functions. Studies show that these cardiac side effects are mostly related to clozapine which is a D2 and 5-HT2A antagonist such as lurasidone. Though not fully understood, it is thought that cardiac events due to antipsychotic drugs occur because of type 1 hypersensitivity and rising levels of pro-inflammatory cytokines. It might also be related to ischemia that free oxygen radicals initiate at the molecular level.

D2 receptors play a critical role in the regulation of heart rate and vascular tone. D2 receptor antagonism may increase the risk of hypertension by changing systemic vascular resistance and heart rate. In addition, inhibition of D2 receptors may lead to loss of the vasodilator effects of dopamine, leading to impaired cardiovascular homeostasis. Similarly 5-HT2A receptors have important effects of cardiac functions. 5-HT2A receptor antagonism, together with imbalances in serotonin levels, may increase heart rate and affect vascular tone, leading to vasoconstriction. It is possible that the increase in systemic vascular resistance and cardiac inotropy through receptor antagonism may cause deterioration in cardiac functions and should be considered in clinical follow-up.

There are a limited number of studies examining the potential effects of lurasidone on cardiac functions. For example, one study reported that lurasidone treatment did not cause a significant prolongation of the QTc interval, while another study reported that the overall cardiac safety profile of lurasidone use was quite favorable. However, more data are needed to compare cardiac side effects between lurasidone and other antipsychotics and how these effects should be managed in clinical practice. The aim of this study is to gain information about the possible cardiac effects of the lurasidone molecule by evaluating left ventricular systolic function with the help of periodic transthoracic echocardiography. In particular, clarifying the potential risks of lurasidone on cardiac health and the clinical significance of these risks is important both to increase patient safety and to optimize treatment processes.

• Study Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Sevil Gulasti Cardiologist Sevil Gulasti; Phone Number: +905054513277; Email: drsevilonay@hotmail.com

Study Locations

• Turkey
  • Zafer
    • Aydin, Zafer, Turkey, 9010
      • Adnan Menderes University
      • Contact: Sevil Gulasti; Phone Number: +905054513277; Email: drsevilonay@hotmail.com
      • Contact: Maide Gizem Cevik; Phone Number: +905348223574

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who apply to Adnan Menderes University Psychiatry Clinic and meet the criteria of inclusion

Description

Inclusion Criteria:

• Aged 18 to 65 years
• Diagnosed with schizophrenia or bipolar disorder by the psychiatry clinic of our center and indicated to use lurasidone molecule
• Hasn't been diagnosed with coronary artery disease, any kind of heart failure or severe valvular disease

Exclusion Criteria:

• Patients who do not agree to participate to the trial
• Patient who do not meet the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients on Lurasidone; Patient who are admitted by the psychiatry clinic of our center and meet the inclusion criteria

Diagnostic test: Global Longitudinal Strain; Global longitudinal strain measurement is a more objective method to determine left ventricular systolic function than traditional eyeballing method. It helps to detect and quantify subtle changes even so it is an emerging method to evaluate the cardiotoxicity of chemotherapeutic drugs. It is planned to compare each selected patient's GLS measurement before starting to use lurasidone and after six months of using it. Hereby our aim is to find if lurasidone has any effect on left ventricular systolic function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lurasidone molecule will affect left ventricular systolic function	We will measure left ventricular global longitudinal strain of each selected patient before starting to use lurasidone and perform the same evaluation for every patient six months later. Since global longitudinal strain measurement is a preferred way to detect subtle changes of wall motions and contractile functions, we will be able detect if this molecule has any negative effect on left ventricular systolic function.	All patients whom are admitted by our psychiatry clinic for the next 6 months will be included.

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General Publications

• Slawinski G, Hawryszko M, Lizewska-Springer A, Nabialek-Trojanowska I, Lewicka E. Global Longitudinal Strain in Cardio-Oncology: A Review. Cancers (Basel). 2023 Feb 3;15(3):986. doi: 10.3390/cancers15030986.
• Alawami M, Wasywich C, Cicovic A, Kenedi C. A systematic review of clozapine induced cardiomyopathy. Int J Cardiol. 2014 Sep 20;176(2):315-20. doi: 10.1016/j.ijcard.2014.07.103. Epub 2014 Aug 1.
• Curto M, Girardi N, Lionetto L, Ciavarella GM, Ferracuti S, Baldessarini RJ. Systematic Review of Clozapine Cardiotoxicity. Curr Psychiatry Rep. 2016 Jul;18(7):68. doi: 10.1007/s11920-016-0704-3.

Helpful Links

• How and Why to Use Global Longitudinal Strain Measurement

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cardiotoxicity; Lurasidone; antipsychotic drugs; Global Longitudinal Strain
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Cardiovascular Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Wounds and Injuries; Pathologic Processes; Heart Diseases; Chemically-Induced Disorders; Mood Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Schizophrenia; Bipolar Disorder; Cardiotoxicity
• Other Study ID Numbers: 2024/164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No