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RECRUITING Phase 4 ClinicalTrials.gov

The Effect Of Lisinopril On Polycythemia

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT07594535

Registry updated: 2026-08-21
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Description

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.

Interventions

  • Lisinopril Tablets (Drug)
    Subjects will be treated with Lisinopril in three phases: Phase 1: Baseline-3 weeks: 2.5 mg dose Phase 2: Weeks 4 - 7: 5 mg dose (2 x 2.5mg tablets) Phase 3: Weeks 8-12: 10 mg dose (4 x 2.5 mg tablets)

Eligibility 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.

Conditions

Polycythemia

Locations

  • Mayo Clinic — Rochester, Minnesota, United States
  • St. Mary's Hospital — Rochester, Minnesota, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record