The Effect Of Lisinopril On Polycythemia (NCT07594535) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Effect Of Lisinopril On Polycythemia
United States30 participantsStarted 2026-07-01
Plain-language summary
The purpose of this study is to evaluate the effect of the (angiotensin-converting enzyme) ACE inhibitor lisinopril on hemoglobin, hematocrit, and erythropoietin levels in patients with secondary polycythemia due to high-oxygen-affinity hemoglobin variants, oxygen-sensing pathway mutations, or other unexplained and potentially irreversible forms of erythrocytosis. This study aims to determine whether ACE inhibition can effectively reduce excessive erythrocytosis by modulating erythropoietin production.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hemoglobin in Men: \>16.5 g/dL (10.3 mmol/L).
* Hemoglobin in Women \>16.0 g/dL (10.0 mmol/L).
* BMI 18-40 kg/m2.
Exclusion Criteria:
* Positive JAK2 gene linked to Polycythemia Vera.
* Current smoker or previous heavy smoker (\>15 pack years) who quit less than 12 months prior to enrollment.
* Resting SpO₂ ≤ 94% on room air.
* Current or recent (within the past 6 months) use of testosterone or androgen supplementation.
* Any confounding respiratory or renal disease, including diagnosed or suspected sleep apnea, or stage 3 and up of chronic kidney disease.
* Any confounding hematologic disease that may alter hemoglobin level.
* Currently treated with ACE inhibitors.
* Currently treated with potassium-sparing diuretics.
* Currently on SGLT2 or use within 4 weeks prior to screening.
* Baseline systolic blood pressure ≤90 mmHg.
* Baseline systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg.
* Occupational exposure associated with chronically elevated COHb (auto repair, etc.).
* History of anaphylaxis or angioedema.
* Pregnant or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hemoglobin
Timeframe: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
2
Change in hematocrit
Timeframe: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
3
Change in erythropoietin
Timeframe: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)