Clinical trial NCT03943927: Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
Official title: Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Atrial Fibrillation
Keywords: Metoprolol
Genotype
Phenotype
CYP2D6
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of post-operative atrial fibrillation
timeFrame: From the end of anesthesia up to hospital discharge; usually 3-4 days
Secondary outcomes:
measure: Rate of genome tailored prescription changes
timeFrame: From the end of anesthesia up to hospital discharge; usually 3-4 days
measure: Length of hospital stay
timeFrame: From end of surgery to hospital discharge; usually 3-4 days
measure: Overall cost of treatment
timeFrame: From end of surgery to hospital discharge; usually 3-4 days
measure: Cost of interventions to control or treat post-operative atrial fibrillation
timeFrame: From end of anesthesia to hospital discharge; usually 3-4 days
measure: Incidence of adverse drug events
timeFrame: From end of anesthesia to hospital discharge; usually 3-4 days
measure: Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider
timeFrame: From end of anesthesia to hospital discharge; usually 3-4 days
measure: Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider.
timeFrame: From end of anesthesia to hospital discharge; usually 3-4 days
measure: Reasons for non-adherence to recommendations
timeFrame: From end of anesthesia to hospital discharge; usually 3-4 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Miklos Kertai, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: