Health TrialsbyHealthPanel

The Effect Of Lisinopril On Polycythemia

ConditionPolycythemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Lisinopril Tablets

    Drug

    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)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: LisinoprilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (dose 0), study day 3 (dose 2.5), study day 5 (dose 5.0), and study day 7 (dose 10.0)
2

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.

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

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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