Post-operative Atrial FibrillationPREEMPTIVENCT03943927
Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
A study testing Guided Metoprolol Management in people with Post-operative Atrial Fibrillation, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Metoprolol is frequently administered to cardiac surgery patients to reduce the incidence of postoperative atrial fibrillation (PoAF). Metoprolol is metabolized by the enzyme CYP2D6, which is known to have many mutations that could influence a patient's ability to metabolize the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Atrial Fibrillation
- What is being tested?
- Guided Metoprolol Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 20 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Scheduled for surgical procedure (coronary artery bypass graft and/or valve repair/replacement) at Vanderbilt University Medical Center
Who cannot join
- History of allergic reactions or contraindications to beta-blockers
- Patients with persistent atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
Metoprolol is frequently administered to cardiac surgery patients to reduce the incidence of postoperative atrial fibrillation (PoAF). Metoprolol is metabolized by the enzyme CYP2D6, which is known to have many mutations that could influence a patient's ability to metabolize the drug. In this prospective clinical trial, the investigators will determine the genotype of CYP2D6 for patients undergoing cardiac surgery, provide an altered dosing recommendation for metoprolol, then report the relative effectiveness in managing PoAF for each pharmacogenetic- guided dosing category. The investigators will also explore the effects of personalized metoprolol dosing recommendations on outcomes in hospital length of stay, cost, and provider participation.
- Conditions
- Post-operative Atrial Fibrillation
- Being tested
- Guided Metoprolol Management
- Keywords
- Metoprolol, Genotype, Phenotype, CYP2D6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Metoprolol ManagementOther
CYP2D6 Genotyping: Consented patients will have blood drawn for genotyping prior to surgery. Patients will be classified as poor metabolizers, intermediate metabolizers, extensive (normal) metabolizers, or ultrafast metabolizers.
Pharmacogenetic- Guided Metoprolol Management: A best practice advisory will be integrated into institutional clinical decision support systems for metoprolol dosing based on metabolic status of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic-guided metoprolol management | Experimental | Not described Receives: Other: Guided Metoprolol Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative atrial fibrillation
Incidence of post-operative atrial fibrillation measured with post-operative electrocardiogram or rhythm strip, or at least two of the following: documentation in the progress notes, nursing notes, discharge summary, and change in medication.
Measured: From the end of anesthesia up to hospital discharge; usually 3-4 days
Secondary outcomes (8)
Rate of genome tailored prescription changes
Rate of genome tailored prescription changes as measured by the proportion of patients in whom metoprolol prescription is based on CYP2D6 metabolizer status.
Measured: From the end of anesthesia up to hospital discharge; usually 3-4 days
Length of hospital stay
Length of hospital stay (in days) after surgery
Measured: From end of surgery to hospital discharge; usually 3-4 days
Overall cost of treatment
Measured: From end of surgery to hospital discharge; usually 3-4 days
Cost of interventions to control or treat post-operative atrial fibrillation
Measured: From end of anesthesia to hospital discharge; usually 3-4 days
Incidence of adverse drug events
Measured: From end of anesthesia to hospital discharge; usually 3-4 days
Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider
Measured: From end of anesthesia to hospital discharge; usually 3-4 days
Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.
Measured: From end of anesthesia to hospital discharge; usually 3-4 days
Reasons for non-adherence to recommendations
Reasons for non-adherence to recommendations; prepopulated choices including 1. clinically inappropriate recommendation 2. provider preference 3. Other (free text option).
Measured: From end of anesthesia to hospital discharge; usually 3-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start5 Mar 2021
- Primary completion24 Oct 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Kertai, Vanderbilt University Medical Center
- Investigators
- Miklos Kertai, MD. PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943927
- Sponsor's protocol ID
- 190578
- Acronym
- PREEMPTIVE
- Status last verified
- Mar 2023
- First submitted
- 7 May 2019
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staben R, Vnencak-Jones CL, Shi Y, Shotwell MS, Absi T, Shah AS, Wanderer JP, Beller M, Kertai MD. Preemptive Pharmacogenetic-Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The Preemptive Pharmacogenetic-Guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery Pilot Trial. J Cardiothorac Vasc Anesth. 2023 Oct;37(10):1974-1982. doi: 10.1053/j.jvca.2023.06.017. Epub 2023 Jun 14.
PubMed 37407326
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
- ClinicalTrials.gov ID
- NCT03943927
- Acronym / sponsor ID
- PREEMPTIVE / 190578
- Conditions
- Post-operative Atrial Fibrillation
- Keywords
- Metoprolol, Genotype, Phenotype, CYP2D6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metoprolol is frequently administered to cardiac surgery patients to reduce the incidence of postoperative atrial fibrillation (PoAF). Metoprolol is metabolized by the enzyme CYP2D6, which is known to have many mutations that could influence a patient's ability to metabolize the drug. In this prospective clinical trial, the investigators will determine the genotype of CYP2D6 for patients undergoing cardiac surgery, provide an altered dosing recommendation for metoprolol, then report the relative effectiveness in managing PoAF for each pharmacogenetic- guided dosing category. The investigators will also explore the effects of personalized metoprolol dosing recommendations on outcomes in hospital length of stay, cost, and provider participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic-guided metoprolol management | Experimental | Other: Guided Metoprolol Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Scheduled for surgical procedure (coronary artery bypass graft and/or valve repair/replacement) at Vanderbilt University Medical Center
Key exclusion criteria (2 listed)
- History of allergic reactions or contraindications to beta-blockers
- Patients with persistent atrial fibrillation
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 |
|---|---|---|
| Guided Metoprolol ManagementCYP2D6 Genotyping: Consented patients will have blood drawn for genotyping prior to surgery. Patients will be classified as poor metabolizers, intermediate metabolizers, extensive (normal) metabolizers, or ultrafast metabolizers. Pharmacogenetic- Guided Metoprolol Management: A best practice advisory will be integrated into institutional clinical decision support systems for metoprolol dosing based on metabolic status of each patient. | Other | Pharmacogenetic-guided metoprolol management |
Primary outcome
Incidence of post-operative atrial fibrillation
Time frame: From the end of anesthesia up to hospital discharge; usually 3-4 days
Incidence of post-operative atrial fibrillation measured with post-operative electrocardiogram or rhythm strip, or at least two of the following: documentation in the progress notes, nursing notes, discharge summary, and change in medication.
8 secondary outcomes
Rate of genome tailored prescription changes
Time frame: From the end of anesthesia up to hospital discharge; usually 3-4 days
Length of hospital stay
Time frame: From end of surgery to hospital discharge; usually 3-4 days
Overall cost of treatment
Time frame: From end of surgery to hospital discharge; usually 3-4 days
Cost of interventions to control or treat post-operative atrial fibrillation
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
Incidence of adverse drug events
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
Reasons for non-adherence to recommendations
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 37407326Staben R, Vnencak-Jones CL, Shi Y, Shotwell MS, Absi T, Shah AS, Wanderer JP, Beller M, Kertai MD. Preemptive Pharmacogenetic-Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The Preemptive Pharmacogenetic-Guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery Pilot Trial. J Cardiothorac Vasc Anesth. 2023 Oct;37(10):1974-1982. doi: 10.1053/j.jvca.2023.06.017. Epub 2023 Jun 14.
- 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.
Miklos Kertai, MD. PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Metoprolol Management in people with Post-operative Atrial Fibrillation, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 inclusion and 2 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 10 Mar 2023. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of post-operative atrial fibrillation (time frame: From the end of anesthesia up to hospital discharge; usually 3-4 days). 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 NCT03943927, 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 10 Mar 2023.