Oxytocin Effects on Cardiac Electrophysiology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Whang, Columbia University
ClinicalTrials.gov Identifier:
NCT01780337
First received: January 29, 2013
Last updated: June 21, 2016
Last verified: June 2016
Results First Received: May 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cardiac Arrhythmia
Interventions: Drug: Oxytocin
Other: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline


Participant Flow:   Overall Study
    Oxytocin     Saline  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Oxytocin: Intranasal dose of 20 IU oxytocin

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.

Saline: Intranasal dose of saline

Total Total of all reporting groups

Baseline Measures
    Oxytocin     Saline     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: years]
Mean (Standard Deviation)
  63.8  (15.5)     68.1  (3.7)     66.0  (11.0)  
Gender  
[units: participants]
     
Female     1     1     2  
Male     5     5     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Electrophysiology Measure of AH Interval   [ Time Frame: Baseline and 30 min ]

2.  Primary:   Change in Electrophysiology Measure of HV Interval   [ Time Frame: Baseline and 30 min ]

3.  Primary:   Change in Electrophysiology Measure of Right Ventricular Refractory Period   [ Time Frame: Baseline and 30 min ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: ww42@cumc.columbia.edu


Publications:


Responsible Party: William Whang, Columbia University
ClinicalTrials.gov Identifier: NCT01780337     History of Changes
Other Study ID Numbers: AAAC7383
Study First Received: January 29, 2013
Results First Received: May 9, 2016
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration