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

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ClinicalTrials.gov Identifier: NCT03943927
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Miklos Kertai, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Post-operative Atrial Fibrillation Other: Guided Metoprolol Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Pharmacogenetic-guided metoprolol management 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of genome tailored prescription changes [ Time Frame: From the end of anesthesia up to hospital discharge; usually 3-4 days ]
    Rate of genome tailored prescription changes as measured by the proportion of patients in whom metoprolol prescription is based on CYP2D6 metabolizer status.

  2. Length of hospital stay [ Time Frame: From end of surgery to hospital discharge; usually 3-4 days ]
    Length of hospital stay (in days) after surgery

  3. Overall cost of treatment [ Time Frame: From end of surgery to hospital discharge; usually 3-4 days ]
  4. Cost of interventions to control or treat post-operative atrial fibrillation [ Time Frame: From end of anesthesia to hospital discharge; usually 3-4 days ]
  5. Incidence of adverse drug events [ Time Frame: From end of anesthesia to hospital discharge; usually 3-4 days ]
  6. 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 ]
  7. 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 ]
  8. Reasons for non-adherence to recommendations [ Time Frame: From end of anesthesia to hospital discharge; usually 3-4 days ]
    Reasons for non-adherence to recommendations; prepopulated choices including 1. clinically inappropriate recommendation 2. provider preference 3. Other (free text option).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943927


Contacts
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Contact: Miklos Kertai, MD, PhD 615-322-4650 miklos.kertai@vumc.org
Contact: Gail Mayo 615-936-1705 gail.mayo@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37212
Contact: Miklos Kertai, MD. PhD    615-936-4650    miklos.kertai@vumc.org   
Contact: Gail Mayo    615-936-1705    gail.mayo@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Miklos Kertai, MD. PhD Vanderbilt University Medical Center

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Responsible Party: Miklos Kertai, Professor of Anesthesiology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03943927     History of Changes
Other Study ID Numbers: 190578
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miklos Kertai, Vanderbilt University Medical Center:
Metoprolol
Genotype
Phenotype
CYP2D6
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action