30 Participants NeededMy employer runs this trial

Lisinopril for Polycythemia

Recruiting at 1 trial location
NM
Overseen ByNancy Meyer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lisinopril, a medication typically used to lower blood pressure, can help people with secondary polycythemia. In this condition, the body produces too many red blood cells due to certain genetic changes or other unexplained reasons. The study aims to determine if lisinopril can reduce these cells by affecting a hormone called erythropoietin. Suitable candidates for this trial have high hemoglobin levels and no history of smoking or specific blood and respiratory problems. As a Phase 4 trial, lisinopril is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

You will need to stop taking ACE inhibitors, potassium-sparing diuretics, and SGLT2 medications if you are currently using them. The trial does not specify other medications, so it's best to discuss with the trial team.

What is the safety track record for this treatment?

Research has shown that lisinopril, an ACE inhibitor, is generally safe for people. It often treats high blood pressure and some altitude-related issues. Studies have found that ACE inhibitors like lisinopril can safely address blood-related problems. Previous human trials have already tested lisinopril, indicating its safety. While mild side effects like dizziness or a cough may occur, serious issues are rare. Consulting a doctor is always advisable if there are any concerns.12345

Why are researchers enthusiastic about this study treatment?

Lisinopril is unique because it offers a different approach to managing polycythemia. Unlike the standard treatments, which often involve phlebotomy or medications like hydroxyurea to reduce red blood cell counts, lisinopril is an angiotensin-converting enzyme (ACE) inhibitor. Researchers are excited because it could potentially regulate blood pressure and improve circulation, offering a dual benefit for patients. This new mechanism of action might provide a safer and potentially more effective option for those who struggle with traditional treatments.

What is the effectiveness track record for lisinopril in treating polycythemia?

Research has shown that lisinopril, a type of medication, can help reduce the overproduction of red blood cells in some forms of polycythemia. This trial will treat participants with lisinopril to assess its effectiveness. Studies have found that medications like lisinopril can lower the percentage of red blood cells in the blood. In some cases, lisinopril significantly reduces both the red blood cell count and the levels of erythropoietin, a hormone that encourages red blood cell production. This suggests that lisinopril may help manage high red blood cell counts by decreasing the activity of this hormone.12346

Who Is on the Research Team?

MJ

Michael Joyner, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with high red blood cell counts (polycythemia), specifically men with hemoglobin over 16.5 and women over 16.0, and a BMI between 18 and 40. It's aimed at those whose condition may be due to certain genetic factors or unknown causes.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lisinopril to evaluate its effect on hemoglobin, hematocrit, and erythropoietin levels

1 week
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lisinopril

Trial Overview

The study tests whether taking lisinopril tablets (a common blood pressure medicine) can lower high red blood cell levels in people with polycythemia caused by specific genetic reasons or unexplained cases.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LisinoprilExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Clinical Trials - The Effect Of Lisinopril On Polycythemia

This study aims to determine whether ACE inhibition can effectively reduce excessive erythrocytosis by modulating erythropoietin production. Participation ...

Lisinopril for Polycythemia · Info for Participants

This study aims to determine whether ACE inhibition can effectively reduce excessive erythrocytosis by modulating erythropoietin production.

ACE inhibitors and cytoreductive therapy in polycythemia vera

Data regarding clinical outcomes, treatments, and laboratory values during the prospective follow-up were recorded at follow-up visits at 12 ...

Angiotensin-converting-enzyme inhibition therapy in ...

Studies in patients with polycythemia have demonstrated that ACEIs are effective in lowering hematocrit values. We used the Studies Of Left Ventricular ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/9549290/

Treatment of post-transplant erythrocytosis

Results: A significative decrease of Hct values and a decrease of serum erythropoietin values was observed in patients treated with lisinopril. Patients treated ...

Renin-angiotensin inhibitors reduce thrombotic complications ...

We found that the use of RASi showed a protective effect from TAEs both in the whole cohort of MPN with hypertension (HR = 0.46; 95%CI 0.21–0.98, p = 0.04)