NCT05704439

Cardiovascular Risk Reduction in Epilepsy

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DRUG	Neurologist Initiated Treatment	Neurologist Initiated Treatment for Hypertension or Hyperlipidemia
OTHER	Placebo	Usual care

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-01-30
• Last updated: 2024-07-25