The Effect Of Lisinopril On Polycythemia
Purpose
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.
Condition
- Polycythemia
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lisinopril |
Patients diagnosed with polycythemia will be treated with Lisinopril, 2.5 mg tablets |
|
Recruiting Locations
Rochester, Minnesota 55902
Nancy Meyer
507-255-0913
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
Detailed Description
Demonstrating that ACE inhibitor therapy with lisinopril lowers hemoglobin, hematocrit, and erythropoietin levels could introduce a novel therapeutic approach for the management of secondary polycythemia due to high-oxygen-affinity hemoglobin variants, oxygen-sensing pathway mutations, or other unexplained and potentially irreversible forms of erythrocytosis, potentially reducing reliance on repeated phlebotomies and lowering thrombotic risk.