Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery

Post-operative Atrial Fibrillation Clinical Trial

— PREEMPTIVE  

Official title:

Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943927
• Other study ID #: 190578
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: November 20, 2022

Study information

• Verified date: March 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 20, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-operative Atrial Fibrillation

Intervention

Other:
• Guided Metoprolol Management
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the end of anesthesia up to hospital discharge; usually 3-4 days
Secondary	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.	From the end of anesthesia up to hospital discharge; usually 3-4 days
Secondary	Length of hospital stay	Length of hospital stay (in days) after surgery	From end of surgery to hospital discharge; usually 3-4 days
Secondary	Overall cost of treatment		From end of surgery to hospital discharge; usually 3-4 days
Secondary	Cost of interventions to control or treat post-operative atrial fibrillation		From end of anesthesia to hospital discharge; usually 3-4 days
Secondary	Incidence of adverse drug events		From end of anesthesia to hospital discharge; usually 3-4 days
Secondary	Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider		From end of anesthesia to hospital discharge; usually 3-4 days
Secondary	Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.		From end of anesthesia to hospital discharge; usually 3-4 days
Secondary	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).	From end of anesthesia to hospital discharge; usually 3-4 days