Back to resultsPreemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery (PREEMPTIVE)
Primary Purpose
Post-operative Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Metoprolol Management
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Atrial Fibrillation focused on measuring Metoprolol, Genotype, Phenotype, CYP2D6
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of allergic reactions or contraindications to beta-blockers
- Patients with persistent atrial fibrillation
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pharmacogenetic-guided metoprolol management
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Length of hospital stay
Length of hospital stay (in days) after surgery
Overall cost of treatment
Cost of interventions to control or treat post-operative atrial fibrillation
Incidence of adverse drug events
Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider
Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.
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).
Full Information
NCT ID
NCT03943927
First Posted
May 7, 2019
Last Updated
March 7, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03943927
Brief Title
Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
Acronym
PREEMPTIVE
Official Title
Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Atrial Fibrillation
Keywords
Metoprolol, Genotype, Phenotype, CYP2D6
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacogenetic-guided metoprolol management
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Guided Metoprolol Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of post-operative atrial fibrillation
Description
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.
Time Frame
From the end of anesthesia up to hospital discharge; usually 3-4 days
Secondary Outcome Measure Information:
Title
Rate of genome tailored prescription changes
Description
Rate of genome tailored prescription changes as measured by the proportion of patients in whom metoprolol prescription is based on CYP2D6 metabolizer status.
Time Frame
From the end of anesthesia up to hospital discharge; usually 3-4 days
Title
Length of hospital stay
Description
Length of hospital stay (in days) after surgery
Time Frame
From end of surgery to hospital discharge; usually 3-4 days
Title
Overall cost of treatment
Time Frame
From end of surgery to hospital discharge; usually 3-4 days
Title
Cost of interventions to control or treat post-operative atrial fibrillation
Time Frame
From end of anesthesia to hospital discharge; usually 3-4 days
Title
Incidence of adverse drug events
Time Frame
From end of anesthesia to hospital discharge; usually 3-4 days
Title
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
Title
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
Title
Reasons for non-adherence to recommendations
Description
Reasons for non-adherence to recommendations; prepopulated choices including 1. clinically inappropriate recommendation 2. provider preference 3. Other (free text option).
Time Frame
From end of anesthesia to hospital discharge; usually 3-4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of allergic reactions or contraindications to beta-blockers
Patients with persistent atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklos Kertai, MD. PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
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