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

CMD01

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.

2024-01-01

2027-01-01

2027-01-01

Not yet recruiting

150

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Comparison of Neurologist initiated treatment of Hypertension or Hyperlipidemia versus usual care', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-02-21