Lisinopril for Secondary Polycythemia in adults
Official title: The Effect Of Lisinopril On Polycythemia
Run by Mayo Clinic · NCT07594535 · Data updated 2026-11-12
This study tests whether the blood pressure medicine lisinopril can lower hemoglobin, hematocrit, and erythropoietin levels in adults with secondary polycythemia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2029 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07594535 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with high hemoglobin/hematocrit levels consistent with secondary polycythemia and without contraindications to ACE inhibitors.
✕Probably not a fit
Patients whose polycythemia is due to other causes not affected by ACE inhibition or who experience adverse effects from lisinopril may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 study evaluates the effect of lisinopril, an ACE inhibitor, on markers of erythrocytosis in adults with secondary polycythemia due to high-oxygen-affinity hemoglobin variants, oxygen-sensing pathway mutations, or other unexplained causes. Participants will receive lisinopril and monitoring of hemoglobin, hematocrit, and erythropoietin to see if the drug reduces excessive red-blood-cell production. The trial aims to determine whether ACE inhibition can provide a novel management approach and potentially reduce the need for repeated phlebotomies and associated thrombotic risk. Safety and tolerability will be assessed, with careful attention to blood pressure and renal function.
Why it matters
Potential benefit: If successful, lisinopril could become a new option to help control erythrocytosis and lower associated health risks.
How similar studies have gone: Other studies have explored ACE inhibitors for erythrocytosis with varying results; this study tests a targeted population and may provide clearer evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
St. Mary's Hospital
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Michael Joyner, MD — Mayo Clinic
- Study coordinator: Nancy Meyer
- Email: meyer.nancy2@mayo.edu
- Phone: 507-255-0913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.