The Effect Of Lisinopril On Polycythemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lisinopril Tablets.
- Who it may be relevant to
- Registry conditions: Polycythemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
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)]
- 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)]
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- St. Mary's Hospital — Rochester
Identifiers
NCT: NCT07594535 · 26-003687