[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484822":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Eplerenone","ACTIVE_COMPARATOR","Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 50 mg eplerenone . At 2 weeks, eplerenone will be increased to 100 mg. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of \\\u003C135\u002F85 mmHg.",[13],"Drug: Eplerenone",{"label":15,"type":10,"description":16,"interventionNames":17},"Chlorthalidone + potassium","Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of \\\u003C135\u002F85 mmHg.",[18,19],"Drug: Chlorthalidone","Drug: Potassium",[21,26,30],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","After the Pre-Treatment Assessment, participants in the eplerenone arm will be given 50 mg eplerenone. At 2 weeks, eplerenone will be increased to 100 mg.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Chlorthalidone","After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.",[15],{"type":22,"name":31,"description":28,"armGroupLabels":32,"otherNames":25},"Potassium",[15],[34],{"name":35,"affiliation":5,"role":36},"Gail K Adler, MD, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","781-223-2686","gadler@bwh.harvard.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57,61],{"name":35,"role":39,"phone":58,"phoneExt":59,"email":60},"617-732-6660","15899","gadler@partners.org",{"name":35,"role":36,"phone":25,"phoneExt":25,"email":25},{"type":36,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gail Kurr Adler","Chief, Cardiovascular Endocrinology Section, Principal Investigator, Professor of Medicine","100484822","phase-4-mineralocorticoid-receptor-coronary-microvascular-function-and-cardiac-efficiency-in-hypertension-100484822",false,"NCT05593055","Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension","Inclusion Criteria:\n\n1. History of hypertension\n\n   1. Seated systolic BP \\\u003C 180 mmHg and diastolic \\\u003C 110 mmHg if on antihypertensives\n   2. Seated systolic BP 141-200 mmHg and\u002For diastolic BP 90-114 mmHg if not on antihypertensives\n2. LVH by echocardiogram\n\n   1. For men: interventricular septum thickness ≥ 12mm\n   2. For women: interventricular septum thickness ≥ 11mm\n3. We will also allow inclusion of people with treated hypothyroidism, pre-diabetes and diabetes controlled by diet, exercise, and\u002For metformin.\n\nExclusion Criteria:\n\n* Use of MR antagonist (eplerenone, spironolactone, or finerenone) or amiloride (amiloride inhibits ENaC, which is a key mediator of MR's actions) within the past year\n* Orthostatic hypotension\n* Major medical illness, including uncontrolled diabetes mellitus (Hemoglobin A1c \\>7.5)\n* LV ejection fraction \\\u003C 40%\n* New York Heart Association class III to IV congestive heart failure or unstable angina\n* A history in the prior 6 months of Q-wave myocardial infarction, stroke, transient ischemic attack, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft\n* History of secondary hypertension\n* Known genetic cardiomyopathy\n* Renal disease (seum creatinine \\>1.5 mg\u002FdL for men and \\>1.3 mg\u002FdL for women)\n* Hepatic disease\n* Bronchospastic lung disease\n* Alcohol or substance abuse\n* Hormone replacement therapy\n* Abnormal values for electrolytes, liver enzymes or TSH\n* Pregnancy or lactation\n* All individuals \\\u003C18 and \\>75 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.","ALL","18 Years","75 Years",{"count":75,"type":76},75,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The investigators' goal is to show that in hypertensive men and women with left ventricular hypertrophy (LVH) treatment with a mineralocorticoid receptor (MR) antagonist, versus a thiazide-like diuretic, will improve coronary microvascular function and cardiac efficiency, which will associate with improvements in LV structure and function. The investigators will achieve this through a randomized, controlled, basic experimental study involving humans (BESH).",[82,83],"Hypertension","Left Ventricular Hypertrophy","2026-04-03",{"date":86,"type":87},"2026-04-06","ACTUAL",{"date":89,"type":87},"2023-08-25",{"date":91,"type":76},"2027-12-31",{"name":5,"class":6},1]