PolycythemiaPhase 4NCT07594535
The Effect Of Lisinopril On Polycythemia
A Phase 4 study testing Lisinopril Tablets in people with Polycythemia, run by Mayo Clinic at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polycythemia
- What is being tested?
- Lisinopril Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Nancy J Meyer, 504-255-0913, meyer.nancy2@mayo.edu
- Recruiting
St. Mary's Hospital
Rochester, Minnesota, 55902
Nancy Meyer, 507-255-0913
Michael Joyner, MD
About this study
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.
Read the 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.
- Conditions
- Polycythemia
- Being tested
- Lisinopril Tablets
- Medical subject headings
- Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisinopril TabletsDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Lisinopril | Experimental | Patients diagnosed with polycythemia will be treated with Lisinopril, 2.5 mg tablets Receives: Drug: Lisinopril Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
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.
Measured: 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
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.
Measured: 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
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)
Measured: Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolycythemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Joyner, M.D., Mayo Clinic
- Investigators
- Michael Joyner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594535
- Sponsor's protocol ID
- 26-003687
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Lisinopril On Polycythemia
- ClinicalTrials.gov ID
- NCT07594535
- Acronym / sponsor ID
- 26-003687
- Conditions
- Polycythemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisinopril | Experimental | Drug: Lisinopril TabletsPatients diagnosed with polycythemia will be treated with Lisinopril, 2.5 mg tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lisinopril TabletsSubjects 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) | Drug | Lisinopril |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Joyner, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lisinopril Tablets in people with Polycythemia, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Meyer (507-255-0913, meyer.nancy2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.