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Not Yet Recruiting NCT05704439

Cardiovascular Risk Reduction in Epilepsy

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

Sex: All
Ages: 40 Years – 79 Years
Phase: NA
Enrollment: 150
Sponsor: University of California, Los Angeles

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.

Eligibility Criteria

Inclusion CriteriaEpilepsy defined as G40.0-G40.9 in the electronic medical record, or seizure disorder prescribed at least one antiseizure medicationAge 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 enrollmentHyperlipidemia 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 agentIntellectual Disability, developmental disorder or autism recorded in the electronic medical record (ICD-10 codes F70-F79, F84)Exclusion Criteria:Stroke or cerebral hemorrhage < 1 yearDocumented poor compliance with treatmentIf intellectually disabled, if there is no caregiver to support or initiate therapyPregnancy or person actively trying to become pregnantBlood Pressure > 180/110Known 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 devicesDiabetes mellitus,Glomerulonephritis treated with or likely to be treated with immunosuppressive therapyeGFR < 20 ml/min /1.73m2 or end-stage renal disease (ESRD)Cardiovascular event, procedure or hospitalization for unstable angina within last 3 monthsSymptomatic heart failure within the past 6 monthsA medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 yearsAny factors judged by the clinic team to be likely to limit adherence to interventions.Failure to obtain informed consent from participantAny organ transplant

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Source: ClinicalTrials.gov (NCT05704439). StuddyBuddy aggregates publicly available trial information.