NCT07594535

Brief 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 potentially irreversible forms of erythrocytosis. This study aims to determine whether ACE inhibition can effectively reduce excessive erythrocytosis by modulating erythropoietin production.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
36mo left

Started Jul 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jul 2029

First Submitted

Initial submission to the registry

May 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Polycythemia

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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)

    Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)

Study Arms (1)

Lisinopril

EXPERIMENTAL

Patients diagnosed with polycythemia will be treated with Lisinopril, 2.5 mg tablets

Drug: Lisinopril Tablets

Interventions

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)

Lisinopril

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Hospital

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Polycythemia

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Michael Joyner, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Meyer

CONTACT

507-255-0913

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)