Oxytocin Effects on Cardiac Electrophysiology

What Was Tested

This registered early phase 1 trial tested Oxytocin.

In this pilot study the investigators will perform a double-blind randomized trial of intranasal oxytocin on measures of cardiac refractoriness, among individuals who are undergoing clinically indicated catheter ablation procedures for paroxysmal atrial fibrillation.

The investigators seek to enroll 20 patients for this study, for the purpose of estimating effect sizes for a larger future study.

It had two arms (groups): Oxytocin (active comparator) and Saline (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

National estimates of SCD or out-of- hospital cardiac arrest range from 400,000 to 450,000 events annually.

Recent evidence has emerged about the potential importance of oxytocin in the cardiovascular response to stress and depression.

Oxytocin is a 9-amino acid peptide that is produced in the hypothalamus and released into the central nervous system and the bloodstream.

Oxytocin has both hormone and neurotransmitter function, and affects targets including the hypothalamus, amygdala, hippocampus, brainstem, heart, uterus, and regions of the spinal cord that regulate the autonomic nervous system.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females older than 18 and younger than 85 years of age. Undergoing catheter ablation for paroxysmal atrial fibrillation. Presenting in sinus rhythm at the time of their procedure.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: left ventricular ejection fraction \<0.40; paced rhythm \>50 percent of the time by device interrogation if a pacemaker is present.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2013-01 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Electrophysiology Measure of AH Interval (time frame: Baseline and 30 min). Change in Electrophysiology Measure of HV Interval (time frame: Baseline and 30 min). Change in Electrophysiology Measure of Right Ventricular Refractory Period (time frame: Baseline and 30 min).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.