Effects of Lurasidone on Left Ventricle Systolic Functions

NCT06695676 | Not Yet Recruiting

• 1 other identifier: 2024/164
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lurasidone Cardiotoxicity; Schizophrenia Patients; Bipolar Disorders

Keywords

Global Longitudinal Strain; Cardiotoxicity; Lurasidone; antipsychotic drugs

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patients on Lurasidone

Patient who are admitted by the psychiatry clinic of our center and meet the inclusion criteria

Diagnostic Test: Global Longitudinal Strain

Interventions

Global Longitudinal Strain DIAGNOSTIC_TEST

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.

Patients on Lurasidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients who do not agree to participate to the trial

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University

Aydin, Zafer, 9010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 36765941 BACKGROUND

• 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.

  PMID: 25131906 BACKGROUND

• 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.

  PMID: 27222142 BACKGROUND

Related Links

• How and Why to Use Global Longitudinal Strain Measurement

MeSH Terms

Conditions

Bipolar Disorder; Cardiotoxicity

Interventions

Global Longitudinal Strain

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Sevil Gulasti Cardiologist Sevil Gulasti

CONTACT

+905054513277; drsevilonay@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

TU (1)