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ACE Inhibitor

ACE Inhibitors for Lupus

Phase 2
Recruiting
Led By Meggan Mackay, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If on corticosteroids, subjects must be on a dose that is ≤ prednisone 10 mg daily, or the equivalent
Subjects must be ≥18 and ≤65 years of age: subjects with age > 65 will be excluded to avoid confounding effects of age on cognitive testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing if the drug lisinopril can help people with lupus by decreasing metabolism in the brain and improving cognitive function.

Who is the study for?
Adults aged 18-65 with stable Systemic Lupus Erythematosus (SLE) can join this trial. They must meet specific SLE diagnostic criteria, have no recent severe neurological issues or drug abuse, and not be on certain medications like high-dose steroids or narcotics. Pregnant women and those with uncontrolled hypertension, diabetes, heart disease, or impaired kidney function are excluded.Check my eligibility
What is being tested?
The study is testing if Lisinopril pills—a centrally acting ACE inhibitor—can improve brain metabolism and cognitive functions such as memory and concentration in SLE patients compared to Benazepril pills which do not act centrally.See study design
What are the potential side effects?
Possible side effects of ACE inhibitors like Lisinopril may include coughing, increased potassium levels that could affect the heart rhythm, low blood pressure especially after the first dose, dizziness due to blood pressure changes, headaches, fatigue and rarely swelling of tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking a low dose of steroids, not more than the equivalent of 10 mg of prednisone daily.
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I am between 18 and 65 years old.
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I understand the study and can give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain Metabolism
Secondary outcome measures
2x2 spatial memory task
Automated Neuropsychological Assessment Metrics (ANAM)
Disease Activity
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CA-ACEiActive Control1 Intervention
Enrolled subjects will begin treatment with a low dose of study drug (5 mg) Study drug will then be titrated up as follows, provided the increased dose is tolerated: Day 3-15 (dosing begins after completion of FIMR Visit 1.1): 5 mg Day 29: 10 mg Day 43: 20 mg Day 57: 40 mg if tolerated Subjects will be required to achieve and maintain a minimum dose of 20 mg daily to ensure adequate dosage of the ACE inhibitor.
Group II: nonCA-ACEiPlacebo Group1 Intervention
Enrolled subjects will begin treatment with a low dose of study drug (5 mg) Study drug will then be titrated up as follows, provided the increased dose is tolerated: Day 3-15 (dosing begins after completion of FIMR Visit 1.1): 5 mg Day 29: 10 mg Day 43: 20 mg Day 57: 40 mg if tolerated Subjects will be required to achieve and maintain a minimum dose of 20 mg daily to ensure adequate dosage of the ACE inhibitor.

Find a Location

Who is running the clinical trial?

Lupus Research AllianceOTHER
5 Previous Clinical Trials
3,830 Total Patients Enrolled
Northwell HealthLead Sponsor
460 Previous Clinical Trials
471,007 Total Patients Enrolled
Meggan Mackay, MDPrincipal InvestigatorThe Feinstein Institute for Medical Research
3 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Benazepril (ACE Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04486118 — Phase 2
Lupus Research Study Groups: CA-ACEi, nonCA-ACEi
Lupus Clinical Trial 2023: Benazepril Highlights & Side Effects. Trial Name: NCT04486118 — Phase 2
Benazepril (ACE Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04486118 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cut-off for partaking in this research study?

"According to the criteria listed alongside this clinical trial, participants must be of legal age (18+) and not exceed 55 years old."

Answered by AI

What is the geographical scope of this research effort?

"This medical trial can be done at 6 different hospitals, including Bronx Lebanon Hospital in Bronx and Andrew Shaw in Manhasset. Additionally, Northwell Rheumatology in Great Neck is another viable option, with three other sites available."

Answered by AI

Can you provide an assessment of the security afforded by CA-ACEi?

"Although CA-ACEi has yet to be proven effective, the existing data on its safety is sufficient enough to rate it a score of 2."

Answered by AI

Are there vacancies for persons to participate in this clinical experiment?

"Per the clinicaltrials.gov website, this clinical research is currently recruiting participants; it was initially posted on October 1st 2021 and was last updated November 15th 2021."

Answered by AI

What criteria must a prospective participant meet to be eligible for this research?

"Candidates must have libman-sacks disease and be in the 18 to 55 age bracket to qualify for this medical research. The study is aiming to recruit 36 participants overall."

Answered by AI

What is the total enrolment number for this trial?

"Affirmative. As per information on clinicaltrials.gov, the trial is actively recruiting participants after beginning to be posted on October 1st 2021 and having its most recent update occur on November 15th 2021. 36 patients must be enrolled from 6 different centres of care."

Answered by AI

To what ailments is CA-ACEi commonly prescribed?

"CA-ACEi is a potential intervention for individuals with pre-existing conditions such as cardiovascular events, diabetic nephropathy and myocardial infarction."

Answered by AI

Has the combination of CA-ACEi been tested in prior trials?

"Currently, 9 clinical trials related to CA-ACEi are being conducted. Two of these research studies have reached Phase 3 status with the majority taking place in Gainesville, Florida and a further 702 sites running associated trials."

Answered by AI

Who else is applying?

What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Centrally Acting ACE Inhibition in SLE
Meggan Mackay, MD 2021. "Centrally Acting ACE Inhibition in SLE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04486118.
All > Systemic Lupus Erythematosus > Lupus
~11 spots leftby Jun 2025
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