Recruiting

Lisinopril

Sponsor:

Mayo Clinic

Code:

NCT07594535

Conditions

Polycythemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lisinopril Tablets

Study Details

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.

Conditions

Polycythemia

Study ID

NCT07594535

Start date

Jul 1, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lisinopril

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

Interventions

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 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Nancy Meyer

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Nancy J Meyer

504-255-0913meyer.nancy2@mayo.edu

St. Mary's Hospital

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Nancy Meyer

507-255-0913

Principal Investigator:

Michael Joyner, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-21.