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

Summary

Clozapine is the only drug approved for Treatment Resistant Schizophrenia. However, it has been associated with many adverse drug reactions including agranulocytosis, myocarditis, sialorrhea, constipation, orthostasis, tachycardia. There are many factors that have impacted the use of clozapine in TRS patients including physician hesitation, patient denial, stopping of drug due to Adverse drug reactions. Although Tachycardia should not be the reason to stop clozapine, but data shows that it leads to discontinuation of drugs in significant patient population. If patient on clozapine develops tachycardia; first orthostasis, myocarditis and systemic infection should be ruled out. Tachycardia traditionally have been treated with B1 adrenergic blockers such as Atenolol. But the problem with beta blocker medications is that significant proportion develops hypotension. Recently developed Ivabradine slows heart rate via I(f) current, and is not associated with much cardiac adverse effects. Recent Clinical trials have been carried out to show its effects on Clozapine associated tachycardia which shows promising results. Some studies suggest using Ivabradine in patient population that have contraindication for beta blockers. Although both of these drugs are used widely in clinical practice, but as Ivabradine is relatively new drug there have been no head-to-head comparison with Atenolol. A recent meta-analysis tried to compare treatment efficacy in these patients, but found no studies that met their inclusion criteria. This current study attempts to make such comparison and guide further research.

Eligibility

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.

Conditions5

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