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Trial · Interventional

CompletedEarly phase 1Results postedRegistry data

Oxytocin Effects on Cardiac Electrophysiology

NCTNCT01780337 (opens ClinicalTrials.gov in a new tab)Other idAAAC7383
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Early phase 1
Enrollment
12 participants (actual)
Sponsor
William Whang · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jan 2013
Primary completion
May 2016
Completion
May 2016
First posted
31 Jan 2013 (estimated)
Last update posted
21 Jul 2016 (estimated)
Conditions
Cardiac Arrhythmia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph Early 1

    Oxytocin Effects on Cardiac Electrophysiology

    NCT01780337

    Jan 2013 to May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • SalineOther

Arms2

  • Active comparator

    Oxytocin

    Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.

  • Placebo comparator

    Saline

    Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Change in Electrophysiology Measure of AH Interval

    Time frame · Baseline and 30 min

    Registry description

    First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.

  2. Change in Electrophysiology Measure of HV Interval

    Time frame · Baseline and 30 min

    Registry description

    First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.

  3. Change in Electrophysiology Measure of Right Ventricular Refractory Period

    Time frame · Baseline and 30 min

    Registry description

    First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 30 min

Change in Electrophysiology Measure of AH Interval

GroupValue (milliseconds)Spread
Oxytocin12.711.2
Saline-1.513.4
Primary outcomeMean· Baseline and 30 min

Change in Electrophysiology Measure of HV Interval

GroupValue (milliseconds)Spread
Oxytocin3.09.2
Saline1.06.0
Primary outcomeMean· Baseline and 30 min

Change in Electrophysiology Measure of Right Ventricular Refractory Period

GroupValue (milliseconds)Spread
Oxytocin-3062.2
Saline524.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinPatients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour. Oxytocin: Intranasal dose of 20 IU oxytocin–0 / 60 / 6
SalinePatients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour. Saline: Intranasal dose of saline–0 / 60 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Systematic review · 2011

3 results

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research.

MacDonald et al. 2011Psychoneuroendocrinologycited by 276

PMID 21429671DOI 10.1016/j.psyneuen.2011.02.015PUB-21429671

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Case report · 1998

1 result

Ventricular tachycardia after oxytocin injection in patients with prolonged Q-T interval syndrome--report of two cases.

Liou et al. 1998Acta anaesthesiologica Sinicacited by 16

PMID 9807850PUB-09807850

Full text at the publisher1 result
Publisher pageSee results (1)

More studies

3 studies on this page

PubMed tag: none · 2011

Oxytocin increases autonomic cardiac control: moderation by loneliness.

Norman et al. 2011Biological psychologycited by 163

PMID 21126557DOI 10.1016/j.biopsycho.2010.11.006PUB-21126557

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2009

Oxytocin protects against negative behavioral and autonomic consequences of long-term social isolation.

Grippo et al. 2009Psychoneuroendocrinologycited by 184

PMID 19553027PMC2841348DOI 10.1016/j.psyneuen.2009.05.017PUB-19553027

Rights unknown
Source link

PubMed tag: none · 1963

CARDIAC EFFECTS OF SYNTHETIC OXYTOCIN (SYNTOCINON).

COVINO et al. 1963American heart journalcited by 3

PMID 14083782DOI 10.1016/0002-8703(63)90317-xPUB-14083782

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * Left ventricular ejection fraction \<0.40 * Paced rhythm \>50 percent of the time by device interrogation if a pacemaker is present

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