Early Phase 1
N=12
Oxytocin Effects on Cardiac Electrophysiology
Cardiac Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT01780337 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Change in Electrophysiology Measure of AH Interval — 12.7; -1.5 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Oxytocin (Drug); Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- William Whang
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Electrophysiology Measure of AH Interval |
12.7; -1.5 | — |
| PRIMARY Change in Electrophysiology Measure of HV Interval |
3.0; 1.0 | — |
| PRIMARY Change in Electrophysiology Measure of Right Ventricular Refractory Period |
-30; 5 | — |
Summary
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.
Eligibility Criteria
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 50 percent of the time by device interrogation if a pacemaker is present
Data sourced from ClinicalTrials.gov (NCT01780337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.