NCT07594535 · Mayo Clinic
The Effect Of Lisinopril On Polycythemia
What this study is about
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.
View original scientific 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
DRUG
Lisinopril Tablets
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)
Primary outcome measures
Change in hemoglobin
Time frame: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
Hemoglobin measures the amount of a protein in red blood cells via blood sample and is reported in grams per deciliter (g/DL) Hemoglobin (Hb) concentration exceeding 16 g/dL in women and 16.5 g/dL in men is considered abnormal.
Change in hematocrit
Time frame: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
Hematocrit (Hct) is measured by determining the percentage of red blood cells (RBCs) in a blood sample. Hematocrit (Hct) ≥ 48% in women and ≥49% in men is considered elevated.
Change in erythropoietin
Time frame: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
Erythropoietin is measured via blood test to detect hormone levels, and is reported in milliunits per milliliter (mU/mL). A normal reference range is generally 4 to 26 mU/mL)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations