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Cardiovascular Risk Reduction in Epilepsy

Primary Purpose

Epilepsy, Hypertension, Hyperlipidemia (E.G., Hypercholesterolemia)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurologist Initiated Treatment
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epilepsy focused on measuring Epilepsy, Hyperlipidemia, Hypertension, Underserved

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Epilepsy defined as G40.0-G40.9 in the electronic medical record, or seizure disorder prescribed at least one antiseizure medication Age 40-79 (age range defined by ACC-ASCVD risk estimator+) Untreated HTN defined as at least two sitting BPs > 130/80 in the last year prior to enrollment or on enrollment Hyperlipidemia defined as LDL > 70 mg/dl with 10-year ACC-ASCVD score > 7.5% or total LDL > 190, or ASCVD recommendation to initiate lipid lowering agent Intellectual Disability, developmental disorder or autism recorded in the electronic medical record (ICD-10 codes F70-F79, F84) Exclusion Criteria: Stroke or cerebral hemorrhage < 1 year Documented poor compliance with treatment If intellectually disabled, if there is no caregiver to support or initiate therapy Pregnancy or person actively trying to become pregnant Blood Pressure > 180/110 Known secondary cause of hypertension that causes concern regarding safety of the protocol. Arm circumference too large or small to allow accurate blood pressure measurement with available devices Diabetes mellitus, Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy eGFR < 20 ml/min /1.73m2 or end-stage renal disease (ESRD) Cardiovascular event, procedure or hospitalization for unstable angina within last 3 months Symptomatic heart failure within the past 6 months A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years Any factors judged by the clinic team to be likely to limit adherence to interventions. Failure to obtain informed consent from participant Any organ transplant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia

    Model 2-Usual Care

    Arm Description

    Neurologist Initiation of antihypertensive or treatment for hyperlipidemia

    Usual care

    Outcomes

    Primary Outcome Measures

    Change in ACC-ASCVD score from baseline
    Percent change in ACC-ASCVD score (ACC-ASCVD) compared with baseline

    Secondary Outcome Measures

    Systolic blood pressure
    change in blood pressure (mmHg)
    Total Cholesterol
    change in total cholesterol (mg/dl) from baseline
    LDL-low density lipoprotein
    change in low density lipoprotein (mg/dl) from baseline
    Compliance
    Percent of enrolled subjects who complete visit three
    Acceptability Rate
    Rate: Number of medication proposals accepted by primary care physicians/number of medication proposals submitted to primary care physicians

    Full Information

    First Posted
    January 11, 2023
    Last Updated
    February 16, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    Olive View-UCLA Education & Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05704439
    Brief Title
    Cardiovascular Risk Reduction in Epilepsy
    Official Title
    Cardiovascular Risk in Epilepsy: Pilot Feasibility and Efficacy Study of Neurologist-Initiated Treatment of Hypertension and Hyperlipidemia in an Underserved Minority Population in Los Angeles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2027 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    Olive View-UCLA Education & Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Epilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population. This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia.
    Detailed Description
    Epilepsy is a disabling and lethal neurological disease which affect 3.47 million Americans. Significant health care disparities exist in people with epilepsy (PWE). PWE are more likely to be Hispanic, Black, developmentally disabled and unemployed. Hypertension and hyperlipidemia are highly prevalent and often go undertreated, and cardiovascular (CV) mortality is higher in people with epilepsy (PWE) than the general population. Preliminary data from our group shows that PWE have higher ACC-ASCVD risk scores than an age matched NHANES cohort without epilepsy. Preliminary data also demonstrate mortality rates in PWE due to hypertension, stroke, and diabetes are rising in the US, counter to the US general population. PWE on Medicaid, Medi-Cal and without insurance are more likely to experience delays to treatment and follow aberrant care pathways. Unexpected seizures and status epilepticus often result in transport to community and public health hospitals, where they are referred to neurology clinics, a process which may bypass primary care. As a result, PWE may have as their primary point of contact neurologists who traditionally do no monitor or treat hypertension or hyperlipidemia. This leads to gaps in care and missed opportunities to reduce CV risk. This proposal seeks to test the feasibility, acceptability, and preliminary efficacy of a new care model for the underserved PWE in a public health setting. In this new model, neurologists guided by standardized treatment algorithms (ACC-ASCVD estimator+) propose and initiate pharmacological interventions for hypertension and hyperlipidemia. We propose enrolling 150 subjects ages 40-79 with untreated or incompletely treated hypertension and/or hyperlipidemia. Subjects will be randomized 2:1 to Neurologist-initiated treatment (Model 1) versus usual care (Model 2). Subjects will be evaluated for blood pressure, blood chemistries, lipids, and HgA1C at baseline, one and three months. At 3-months, subjects randomized to usual care (Model 2) will be offered treatment if not yet initiated by primary care. If successful, results of this pilot study will provide needed feasibility and preliminary efficacy data for a large multicenter randomized trial of Neurologist initiated treatment of cardiovascular risk in the underserved with epilepsy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Hypertension, Hyperlipidemia (E.G., Hypercholesterolemia)
    Keywords
    Epilepsy, Hyperlipidemia, Hypertension, Underserved

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Comparison of Neurologist initiated treatment of Hypertension or Hyperlipidemia versus usual care
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia
    Arm Type
    Active Comparator
    Arm Description
    Neurologist Initiation of antihypertensive or treatment for hyperlipidemia
    Arm Title
    Model 2-Usual Care
    Arm Type
    Placebo Comparator
    Arm Description
    Usual care
    Intervention Type
    Drug
    Intervention Name(s)
    Neurologist Initiated Treatment
    Other Intervention Name(s)
    antihypertensive agent or Hyperlipidemia agent
    Intervention Description
    Neurologist Initiated Treatment for Hypertension or Hyperlipidemia
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Usual Care
    Intervention Description
    Usual care
    Primary Outcome Measure Information:
    Title
    Change in ACC-ASCVD score from baseline
    Description
    Percent change in ACC-ASCVD score (ACC-ASCVD) compared with baseline
    Time Frame
    3-months
    Secondary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    change in blood pressure (mmHg)
    Time Frame
    3 months
    Title
    Total Cholesterol
    Description
    change in total cholesterol (mg/dl) from baseline
    Time Frame
    3 months
    Title
    LDL-low density lipoprotein
    Description
    change in low density lipoprotein (mg/dl) from baseline
    Time Frame
    3 months
    Title
    Compliance
    Description
    Percent of enrolled subjects who complete visit three
    Time Frame
    3 months
    Title
    Acceptability Rate
    Description
    Rate: Number of medication proposals accepted by primary care physicians/number of medication proposals submitted to primary care physicians
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Epilepsy defined as G40.0-G40.9 in the electronic medical record, or seizure disorder prescribed at least one antiseizure medication Age 40-79 (age range defined by ACC-ASCVD risk estimator+) Untreated HTN defined as at least two sitting BPs > 130/80 in the last year prior to enrollment or on enrollment Hyperlipidemia defined as LDL > 70 mg/dl with 10-year ACC-ASCVD score > 7.5% or total LDL > 190, or ASCVD recommendation to initiate lipid lowering agent Intellectual Disability, developmental disorder or autism recorded in the electronic medical record (ICD-10 codes F70-F79, F84) Exclusion Criteria: Stroke or cerebral hemorrhage < 1 year Documented poor compliance with treatment If intellectually disabled, if there is no caregiver to support or initiate therapy Pregnancy or person actively trying to become pregnant Blood Pressure > 180/110 Known secondary cause of hypertension that causes concern regarding safety of the protocol. Arm circumference too large or small to allow accurate blood pressure measurement with available devices Diabetes mellitus, Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy eGFR < 20 ml/min /1.73m2 or end-stage renal disease (ESRD) Cardiovascular event, procedure or hospitalization for unstable angina within last 3 months Symptomatic heart failure within the past 6 months A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years Any factors judged by the clinic team to be likely to limit adherence to interventions. Failure to obtain informed consent from participant Any organ transplant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher M DeGiorgio, MD
    Phone
    17472103104
    Email
    cdegiorgio@dhs.lacounty.gov
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diana Murray
    Phone
    17472103104
    Email
    dimurray@dhs.lacounty.gov
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher M DeGiorgio, MD
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    pending

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    Cardiovascular Risk Reduction in Epilepsy

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