Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how two different medications, Atenolol and Ivabradine, can help manage a fast heart rate (tachycardia) in patients with Treatment Resistant Schizophrenia (TRS) who are taking Clozapine. Clozapine is often the only effective treatment for TRS, but it can cause side effects, including an increased heart rate. While Atenolol is commonly used to treat fast heart rates, it can sometimes lead to low blood pressure, which can be a problem. Ivabradine is a newer medication that can also help slow down the heart rate without the same risks, but it hasn't been directly compared to Atenolol until now.

To participate in this trial, patients must be between 18 and 60 years old, diagnosed with TRS, and have a resting heart rate above 100 beats per minute. They should not be currently taking either Atenolol or Ivabradine or have serious health issues that could interfere with the study. Participants will be closely monitored as they receive one of the two medications to see which one works better for controlling their heart rate while on Clozapine. This study aims to provide valuable information that could help guide future treatment options for patients facing these challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All patients coming for treatment at the Out-patient department and In-patient department of the Department of Psychiatry fulfilling the following are included:
• • 1. Patients diagnosed with TRS (TRRIP consensus) receiving clozapine.
• • 2. Aged between 18 to 60 years of either sex
• • 3. Having baseline heart rate of \>100/minute.
• • 4. Written informed consent from Legally Authorized representative.
• Exclusion Criteria:
• Patients with any one of the following are excluded from the study:
• • 1. Already receiving Atenolol or Ivabradine.
• • 2. Patients having any contraindication to using Atenolol or Ivabradine.
• • 3. Receiving any other medication other than Clozapine known to cause autonomic dysregulation.
• • 4. Active substance use.
• • 5. Serious medical or neurological comorbidity.