ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    11673340 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Oxytocin Effects on Cardiac Electrophysiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01780337
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : June 17, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
William Whang, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cardiac Arrhythmia
Interventions Drug: Oxytocin
Other: Saline
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Oxytocin Saline Total
Hide Arm/Group Description

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
63.8  (15.5) 68.1  (3.7) 66.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
1
  16.7%
2
  16.7%
Male
5
  83.3%
5
  83.3%
10
  83.3%
1.Primary Outcome
Title Change in Electrophysiology Measure of AH Interval
Hide 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.
Time Frame Baseline and 30 min
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 3 out of 6 were evaluable for the Oxytocin group. Only 2 out of 6 were evaluable for the Saline group.
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: milliseconds
12.7  (11.2) -1.5  (13.4)
2.Primary Outcome
Title Change in Electrophysiology Measure of HV Interval
Hide 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.
Time Frame Baseline and 30 min
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 4 out of 6 were evaluable for the Oxytocin group. Only 5 out of 6 were evaluable for the Saline group.
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: milliseconds
3.0  (9.2) 1.0  (6.0)
3.Primary Outcome
Title Change in Electrophysiology Measure of Right Ventricular Refractory Period
Hide 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.
Time Frame Baseline and 30 min
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 4 out of 6 were evaluable for the Oxytocin group.
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description:

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: milliseconds
-30  (62.2) 5  (24.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Saline
Hide Arm/Group Description

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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

All-Cause Mortality
Oxytocin Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxytocin Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William Whang
Organization: Columbia University
Phone: 212-305-8620
Publications:
Responsible Party: William Whang, Columbia University
ClinicalTrials.gov Identifier: NCT01780337     History of Changes
Other Study ID Numbers: AAAC7383
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: May 9, 2016
Results First Posted: June 17, 2016
Last Update Posted: July 21, 2016