[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07594535":3,"trial-entities:NCT07594535":104,"trial-summary:NCT07594535":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":70,"locations":73,"central_contacts":98,"overall_officials":100,"references":102,"see_also_links":103},"NCT07594535","26-003687","The Effect Of Lisinopril On Polycythemia","RECRUITING","2029-07-01","2026-08","2026-08-21","2026-07-01","Mayo Clinic","OTHER",false,"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.","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.",[18],"Polycythemia",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE4",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Lisinopril Tablets","Subjects will be treated with Lisinopril in three phases:\n\nPhase 1:\n\nBaseline-3 weeks: 2.5 mg dose\n\nPhase 2:\n\nWeeks 4 - 7: 5 mg dose (2 x 2.5mg tablets)\n\nPhase 3:\n\nWeeks 8-12: 10 mg dose (4 x 2.5 mg tablets)",[33],"Lisinopril",[35,39,42],{"measure":36,"description":37,"timeFrame":38},"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\u002FDL) Hemoglobin (Hb) concentration exceeding 16 g\u002FdL in women and 16.5 g\u002FdL 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)",{"measure":40,"description":41,"timeFrame":38},"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.",{"measure":43,"description":44,"timeFrame":38},"Change in erythropoietin","Erythropoietin is measured via blood test to detect hormone levels, and is reported in milliunits per milliliter (mU\u002FmL). A normal reference range is generally 4 to 26 mU\u002FmL)",[],"ALL","18 Years","80 Years",{"inclusion":50,"exclusion":54,"raw_text":69},[51,52,53],"Hemoglobin in Men: \\>16.5 g\u002FdL (10.3 mmol\u002FL).","Hemoglobin in Women \\>16.0 g\u002FdL (10.0 mmol\u002FL).","BMI 18-40 kg\u002Fm2.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68],"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.","Inclusion Criteria:\n\n* Hemoglobin in Men: \\>16.5 g\u002FdL (10.3 mmol\u002FL).\n* Hemoglobin in Women \\>16.0 g\u002FdL (10.0 mmol\u002FL).\n* BMI 18-40 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Positive JAK2 gene linked to Polycythemia Vera.\n* Current smoker or previous heavy smoker (\\>15 pack years) who quit less than 12 months prior to enrollment.\n* Resting SpO₂ ≤ 94% on room air.\n* Current or recent (within the past 6 months) use of testosterone or androgen supplementation.\n* Any confounding respiratory or renal disease, including diagnosed or suspected sleep apnea, or stage 3 and up of chronic kidney disease.\n* Any confounding hematologic disease that may alter hemoglobin level.\n* Currently treated with ACE inhibitors.\n* Currently treated with potassium-sparing diuretics.\n* Currently on SGLT2 or use within 4 weeks prior to screening.\n* Baseline systolic blood pressure ≤90 mmHg.\n* Baseline systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg.\n* Occupational exposure associated with chronically elevated COHb (auto repair, etc.).\n* History of anaphylaxis or angioedema.\n* Pregnant or breastfeeding.",[71,72],"ADULT","OLDER_ADULT",[74,88],{"facility":12,"status":7,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Rochester","Minnesota","55902","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Nancy J Meyer","CONTACT","504-255-0913","meyer.nancy2@mayo.edu",{"lat":86,"lon":87},44.02163,-92.4699,{"facility":89,"status":7,"city":75,"state":76,"zip":77,"country":78,"contacts":90,"geoPoint":97},"St. Mary's Hospital",[91,94],{"name":92,"role":82,"phone":93},"Nancy Meyer","507-255-0913",{"name":95,"role":96},"Michael Joyner, MD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},[99],{"name":92,"role":82,"phone":93,"email":84},[101],{"name":95,"affiliation":12,"role":96},[],[],{"nct_id":4,"conditions":105,"biomarkers":106},[18],[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study involving 30 participants. Participants will receive increasing doses of Lisinopril over 12 weeks.","completed","Lisinopril for Polycythemia Study","This study is testing if a medication called Lisinopril can help people with polycythemia (a condition where you have too many red blood cells). Researchers want to see if Lisinopril can lower levels of hemoglobin (a protein in red blood cells), hematocrit (the percentage of red blood cells in your blood), and erythropoietin (a hormone that tells your body to make red blood cells). You might be able to join if you are between 18 and 80 years old and have high hemoglobin levels, but not if you have a specific genetic mutation (JAK2) or are a current or recent heavy smoker. The study is looking for 30 participants, but its current status is unclear.","Your hemoglobin, hematocrit, and erythropoietin levels will be measured at baseline and on study days 3, 5, and 7.",115,"You would take Lisinopril tablets daily, starting at 2.5 mg and increasing to 10 mg over 12 weeks. Blood tests will be done at baseline and on specific days during the study.","Not stated in the trial record.",[],"v2"]