Cardiovascular Risk Reduction in Epilepsy

NCT05704439 | Withdrawn DMC

• 1 other identifier: CMD01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Epilepsy; Hyperlipidemia; Hypertension; Underserved

Outcome Measures

Primary Outcomes (1)

• Change in ACC-ASCVD score from baseline

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

  3-months

Secondary Outcomes (5)

• Systolic blood pressure

  3 months

• Total Cholesterol

  3 months

• LDL-low density lipoprotein

  3 months

• Compliance

  3 months

• Acceptability Rate

  3 months

Study Arms (2)

Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia

ACTIVE COMPARATOR

Neurologist Initiation of antihypertensive or treatment for hyperlipidemia

Drug: Neurologist Initiated Treatment

Model 2-Usual Care

PLACEBO COMPARATOR

Usual care

Other: Placebo

Interventions

Neurologist Initiated Treatment DRUG

Neurologist Initiated Treatment for Hypertension or Hyperlipidemia

Also known as: antihypertensive agent or Hyperlipidemia agent

Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia

Placebo OTHER

Usual care

Also known as: Usual Care

Model 2-Usual Care

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Olive View-UCLA Education & Research Institute: collaborator

MeSH Terms

Conditions

Epilepsy; Hypertension; Hyperlipidemias; Hypercholesterolemia

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Christopher M DeGiorgio, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology in Residence

Model Details: Randomized Comparison of Neurologist initiated treatment of Hypertension or Hyperlipidemia versus usual care

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 30, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share