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High Blood Pressure Drug for Lupus-Related Heart Disease

Phase 4
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients >20 years with Lupus according to ACR criteria
Be older than 18 years old
Must not have
Known contraindication to dipyridamole
Renal artery stenosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is investigating whether a common drug used to treat high blood pressure could also help treat an autoimmune disease that mainly affects women. The disease, lupus, can cause damage to the heart, and this trial is looking at whether the drug can help improve heart function in patients with lupus.

Who is the study for?
This trial is for adults over 20 with Systemic Lupus Erythematosus (SLE) who show abnormal heart muscle blood flow but no major artery blockages. It's not for those allergic to certain stress test drugs, with steroid-dependent asthma, a history of swelling under the skin, kidney artery narrowing, high serum creatinine levels, or pregnant/breastfeeding women. Also excluded are those unable to do light exercise or currently on ACE inhibitors/ARBs/nitrates.
What is being tested?
The study investigates if endothelial dysfunction (blood vessel issues) contributes to heart disease in SLE patients by measuring blood vessel dilation and comparing it with heart perfusion and SLE activity. Some will undergo angiography. The trial also tests whether Quinapril (an ACE inhibitor) can improve these conditions versus a placebo in a crossover design where participants switch treatments midway.
What are the potential side effects?
Quinapril may cause coughing, dizziness due to low blood pressure, kidney problems, elevated blood potassium levels which can affect the heart rhythm and rarely angioedema (swelling beneath the skin). Side effects often vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 20 years old and have been diagnosed with Lupus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or react badly to dipyridamole.
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I have a narrowed artery to my kidney.
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I am currently taking ACE inhibitors, ARBs, or nitrates.
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I rely on steroids to manage my asthma.
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I cannot take ACE inhibitors due to an allergy or other reaction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

Heart and Stroke Foundation of CanadaOTHER
129 Previous Clinical Trials
72,561 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,194 Total Patients Enrolled
Robert M Iwanochko, MDStudy DirectorUniversity Health Network, Toronto

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT00188188 — Phase 4
Lupus Research Study Groups:
Lupus Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT00188188 — Phase 4
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00188188 — Phase 4
~2 spots leftby Nov 2025
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