EpilepsyNCT05704439
Cardiovascular Risk Reduction in Epilepsy
A study testing Neurologist Initiated Treatment in people with Epilepsy and Hypertension, run by University of California, Los Angeles.
Trial 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)… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Epilepsy, Hypertension, Hyperlipidemia (E.G., Hypercholesterolemia)
- What is being tested?
- Neurologist Initiated Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 16Show fewer
- 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
About this study
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
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.
Read the 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
- Being tested
- Neurologist Initiated Treatment, Placebo
- Keywords
- Epilepsy, Hyperlipidemia, Hypertension, Underserved
- Medical subject headings
- Epilepsy, Hypertension, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurologist Initiated TreatmentDrug
Also called antihypertensive agent or Hyperlipidemia agent
Neurologist Initiated Treatment for Hypertension or Hyperlipidemia
PlaceboOther
Also called Usual Care
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia | Active comparator | Neurologist Initiation of antihypertensive or treatment for hyperlipidemia Receives: Drug: Neurologist Initiated Treatment |
| Model 2-Usual Care | Placebo comparator | Usual care Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ACC-ASCVD score from baseline
Percent change in ACC-ASCVD score (ACC-ASCVD) compared with baseline
Measured: 3-months
Secondary outcomes (5)
Systolic blood pressure
change in blood pressure (mmHg)
Measured: 3 months
Total Cholesterol
change in total cholesterol (mg/dl) from baseline
Measured: 3 months
LDL-low density lipoprotein
change in low density lipoprotein (mg/dl) from baseline
Measured: 3 months
Compliance
Percent of enrolled subjects who complete visit three
Measured: 3 months
Acceptability Rate
Rate: Number of medication proposals accepted by primary care physicians/number of medication proposals submitted to primary care physicians
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Comparison of Neurologist initiated treatment of Hypertension or Hyperlipidemia versus usual care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Olive View-UCLA Education & Research Institute
- Responsible party
- Principal investigator, Christopher Degiorgio, MD FAAN, University of California, Los Angeles
- Investigators
- Christopher M DeGiorgio, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704439
- Sponsor's protocol ID
- CMD01
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: pending
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704439
- Acronym / sponsor ID
- CMD01
- Keywords
- Epilepsy, Hyperlipidemia, Hypertension, Underserved
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Olive View-UCLA Education & Research Institute
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Comparison of Neurologist initiated treatment of Hypertension or Hyperlipidemia versus usual care
| Arm | Type | Receives |
|---|---|---|
| Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia | Active comparator | Drug: Neurologist Initiated TreatmentNeurologist Initiation of antihypertensive or treatment for hyperlipidemia |
| Model 2-Usual Care | Placebo comparator | Other: PlaceboUsual care |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurologist Initiated TreatmentAlso: antihypertensive agent or Hyperlipidemia agentNeurologist Initiated Treatment for Hypertension or Hyperlipidemia | Drug | Model 1-Neurologist Initiation of Treatment for Hypertension or Hyperlipidemia |
| PlaceboAlso: Usual CareUsual care | Other | Model 2-Usual Care |
Primary outcome
Change in ACC-ASCVD score from baseline
Time frame: 3-months
Percent change in ACC-ASCVD score (ACC-ASCVD) compared with baseline
5 secondary outcomes
Systolic blood pressure
Time frame: 3 months
Total Cholesterol
Time frame: 3 months
LDL-low density lipoprotein
Time frame: 3 months
Compliance
Time frame: 3 months
Acceptability Rate
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No. pending
Related trials for Epilepsy
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Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
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Combined CM and STN Stimulation for Motor Epilepsy
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Lily's Grace Temporal Interference
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Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher M DeGiorgio, MD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Neurologist Initiated Treatment in people with Epilepsy and Hypertension, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ACC-ASCVD score from baseline (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.