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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

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

ArmDescriptionAssigned Intervention
Experimental
Lisinopril 		Patients diagnosed with polycythemia will be treated with Lisinopril, 2.5 mg tablets
  • 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)

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55902
Contact:
Nancy J Meyer
504-255-0913
meyer.nancy2@mayo.edu

St. Mary's Hospital
Rochester, Minnesota 55902
Contact:
Nancy Meyer
507-255-0913

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Nancy Meyer
507-255-0913
meyer.nancy2@mayo.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.