Cardiac ArrythmiasPhase 4CaRDIONCT03716076
Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
A Phase 4 study testing Carbetocin in people with Cardiac Arrythmias, run by University of British Columbia at 1 site in Canada.
Trial summary
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrythmias
- What is being tested?
- Carbetocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 24 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
- American Society of Anesthesiologists (ASA) class 2
- Patients ≥ 19 years of age
Who cannot join
- Long QT syndrome
- Cardiac disease or rhythm abnormalities
- Family history of long QT syndrome or abnormal cardiac conduction
- Currently taking medication that is known to prolong the QT interval
- Women who are high risk for uterine atony as outlined in SOGC
- Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
- Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Read the detailed description
Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics
- Conditions
- Cardiac Arrythmias
- Being tested
- Carbetocin
- Keywords
- Carbetocin, Myocardial repolarization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
50 mcg or 100 mcg bolus of carbetocin
| Study group | Role | What they receive |
|---|---|---|
| Participant receives 50 mcg of carbetocin post-delivery. | Experimental | Participant receives 50 mcg of carbetocin post-delivery. Receives: Drug: Carbetocin |
| Participant receives 100 mcg of carbetocin post-delivery. | Experimental | Participant receives 100 mcg of carbetocin post-delivery. Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tp-e
Time interval between peak and end of T-wave (Tp-e)
Measured: 5 minutes post-carbetocin administration
Secondary outcomes (6)
Arrhythmia
Occurrence of Atrial or Ventricular Arrhythmias
Measured: perioperatively, typically ranging 30 minutes-1 hour
QTc at 5 Min
Bazette corrected Q-T interval
Measured: 5 min post-carbetocin administration
QTc 10 Min
Bazette corrected Q-T interval (QTc)
Measured: 10 minutes post-carbetocin administration
QTc 5 Min Spinal
Bazette corrected Q-T interval change after spinal anesthesia
Measured: 5 min post-administration of spinal anesthesia
Tp-e 5 Min Post-spinal
Time between peak and end of T-wave,
Measured: 5 minutes after administration of spinal anesthesia
Tp-e at 10 Min
Time between peak and end of T-wave
Measured: 10 minutes post-carbetocin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion15 Jun 2019
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD MMSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716076
- Sponsor's protocol ID
- H18-02232
- Acronym
- CaRDIO
- Status last verified
- Apr 2021
- First submitted
- 17 Oct 2018
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clunies-Ross N, Roston TM, Taylor J, Whyte S, Albert A, Gorges M, Chau A. The Effect of Carbetocin Dose on Transmural Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective, Randomized Clinical Trial. Anesth Analg. 2021 Feb 1;132(2):485-492. doi: 10.1213/ANE.0000000000004712.
PubMed 32149759
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03716076
- Acronym / sponsor ID
- CaRDIO / H18-02232
- Conditions
- Cardiac Arrythmias
- Keywords
- Carbetocin, Myocardial repolarization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Detailed description
Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant receives 50 mcg of carbetocin post-delivery. | Experimental | Drug: CarbetocinParticipant receives 50 mcg of carbetocin post-delivery. |
| Participant receives 100 mcg of carbetocin post-delivery. | Experimental | Drug: CarbetocinParticipant receives 100 mcg of carbetocin post-delivery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
- American Society of Anesthesiologists (ASA) class 2
- Patients ≥ 19 years of age
Key exclusion criteria (7 listed)
- Long QT syndrome
- Cardiac disease or rhythm abnormalities
- Family history of long QT syndrome or abnormal cardiac conduction
- Currently taking medication that is known to prolong the QT interval
- Women who are high risk for uterine atony as outlined in SOGC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbetocin50 mcg or 100 mcg bolus of carbetocin | Drug | Participant receives 100 mcg of carbetocin post-delivery., Participant receives 50 mcg of carbetocin post-delivery. |
Primary outcome
Tp-e
Time frame: 5 minutes post-carbetocin administration
Time interval between peak and end of T-wave (Tp-e)
6 secondary outcomes
Arrhythmia
Time frame: perioperatively, typically ranging 30 minutes-1 hour
QTc at 5 Min
Time frame: 5 min post-carbetocin administration
QTc 10 Min
Time frame: 10 minutes post-carbetocin administration
QTc 5 Min Spinal
Time frame: 5 min post-administration of spinal anesthesia
Tp-e 5 Min Post-spinal
Time frame: 5 minutes after administration of spinal anesthesia
Tp-e at 10 Min
Time frame: 10 minutes post-carbetocin administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32149759Clunies-Ross N, Roston TM, Taylor J, Whyte S, Albert A, Gorges M, Chau A. The Effect of Carbetocin Dose on Transmural Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective, Randomized Clinical Trial. Anesth Analg. 2021 Feb 1;132(2):485-492. doi: 10.1213/ANE.0000000000004712.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Chau, MD MMSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carbetocin in people with Cardiac Arrythmias, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tp-e (time frame: 5 minutes post-carbetocin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.