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NCT03716076: CaRDIO

Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

Completed Phase 4 Results posted Last updated 14 May 2021
What this trial tests

Phase 4 trial testing Carbetocin in Cardiac Arrythmias in 50 participants. Completed in 24 April 2020.

Timeline
1 November 2018
Primary endpoint
15 June 2019
24 April 2020

Quick facts

Lead sponsorUniversity of British Columbia
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposediagnostic
Enrollment50
Start date1 November 2018
Primary completion15 June 2019
Estimated completion24 April 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

19 and older, female only, with Cardiac Arrythmias. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tp-e Primary · 5 minutes post-carbetocin administration

Time interval between peak and end of T-wave (Tp-e)

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.69.5± 7.7
Participant Receives 100 mcg of Carbetocin Post-delivery.74.7± 4.7
Arrhythmia Secondary · perioperatively, typically ranging 30 minutes-1 hour

Occurrence of Atrial or Ventricular Arrhythmias

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.0
Participant Receives 100 mcg of Carbetocin Post-delivery.0
QTc at 5 Min Secondary · 5 min post-carbetocin administration

Bazette corrected Q-T interval

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.435.1± 18.3
Participant Receives 100 mcg of Carbetocin Post-delivery.434.2± 18.8
QTc 10 Min Secondary · 10 minutes post-carbetocin administration

Bazette corrected Q-T interval (QTc)

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.431.6± 18.2
Participant Receives 100 mcg of Carbetocin Post-delivery.431.9± 15.4
QTc 5 Min Spinal Secondary · 5 min post-administration of spinal anesthesia

Bazette corrected Q-T interval change after spinal anesthesia

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.409.4± 19.2
Participant Receives 100 mcg of Carbetocin Post-delivery.413.6± 17.4
Tp-e 5 Min Post-spinal Secondary · 5 minutes after administration of spinal anesthesia

Time between peak and end of T-wave,

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.69.5± 8.6
Participant Receives 100 mcg of Carbetocin Post-delivery.70.9± 6.5
Tp-e at 10 Min Secondary · 10 minutes post-carbetocin administration

Time between peak and end of T-wave

GroupValue95% CI
Participant Receives 50 mcg of Carbetocin Post-delivery.69.4± 8.2
Participant Receives 100 mcg of Carbetocin Post-delivery.71.8± 5.5

Sponsor's own description

Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Carbetocin

Trials testing the same drug.

Other recruiting trials for Cardiac Arrythmias

Currently open trials in the same condition.

Other University of British Columbia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03716076.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing