[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520352":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":35,"studyPopulation":23,"armGroups":36,"interventions":47,"overallOfficials":58,"centralContacts":63,"locations":68,"responsibleParty":100,"collaborators":23,"id":102,"slug":23,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":23,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":23,"enrollmentInfo":110,"targetDuration":23,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":71,"whyStopped":23,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change of left atrial volume index","Changes in Left Atrial Volume Index (LAVI, mL\u002Fm2) as measured by MRI from baseline to 6 months.","6 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change of cardiac structure and functional","1. Left ventricular functional indicators: Echocardiography\u002FMagnetic Resonance Imaging measured Left Ventricular Ejection Fraction (LVEF, %), the ratio of early mitral inflow velocity to early diastolic mitral annular velocity (E\u002Fe', cm\u002Fs), and Global Longitudinal Strain (GLS, %).\n2. Left ventricular structural indicators: Echocardiography\u002FMagnetic Resonance Imaging measured Left Ventricular Mass Index (LVMI, g\u002Fm2).\n3. Left atrial functional indicators: Echocardiography\u002FMagnetic Resonance Imaging measured Left Atrial Ejection Fraction (LAEF, %) and echocardiography measured Left Atrial Volume Index (LAVI, mL\u002Fm2).",{"measure":18,"description":19,"timeFrame":12},"Biomarkers","Biomarker concentrations were measured as follows:\n\n1. NT-pro BNP in picograms per milliliter (pg\u002FmL).\n2. Cardiac Troponin I in nanograms per milliliter (ng\u002FmL).\n3. Cardiac Fibrosis Biomarkers, including Collagen type I alpha 1 (Col1A1) in nanograms per milliliter, Matrix Metalloproteinases (MMP-2, MMP-3, MMP-4) in picograms per milliliter (pg\u002FmL) and soluble ST2 protein (sST-2) in nanograms per milliliter (ng\u002FmL).\n4. Inflammation Biomarkers, including High-sensitivity C-reactive protein (hs-CRP) in milligrams per liter (mg\u002FL) and Interleukin-6 (IL-6), Interleukin-1β (IL-1β), and Galectin-3 (Gal-3) in picograms per milliliter (pg\u002FmL).",{"measure":21,"description":22,"timeFrame":12},"Estimated Glomerular Filtration Rate (eGFR)","Change of eGFR",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":29,"maskingDescription":23,"whoMasked":30},"QUADRUPLE",[31,32,33,34],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Hypertension is the leading risk factor of heart failure with preserved heart failure. The overall control rate is about 16% in China. Given the large amounts of hypertensive patients at pre-heart failure (stage B), it's critical to explore the effect of additional cardioprotective medication in addition to well-controlled blood pressure. Sodium-glucose cotransporter-2 inhibitors (engagliflozin) have been shown to improve cardiac function or prognosis in patients with diabetes or heart failure. However, whether it has a cardioprotective effect on hypertensive patients with pre-heart failure and without diabetes remains unknown. We will conduct a multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes. We will enroll 120 eligible patients randomized to receive a placebo or engagliflozin (10mg\u002Fd) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. The secondary endpoints include echocardiography or magnetic resonance imaging to measure structural and functional parameters, blood pressure, glucose, and blood biomarkers of inflammation and fibrosis. We sought to comprehensively evaluate the effect of empagliflozin on the structure and function and explore the underlying mechanisms to provide insights and evidence for the prevention of heart failure in hypertensive patients.",[37,42],{"label":38,"type":39,"description":23,"interventionNames":40},"Empagliflozin","EXPERIMENTAL",[41],"Drug: Empagliflozin 10 MG",{"label":43,"type":44,"description":23,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR",[46],"Drug: Placebo",[48,55],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","Empagliflozin 10 MG","Each participant in the empagliflozin treatment group takes a daily dose of 10mg.",[38],[54],"Jardiance®",{"type":49,"name":43,"description":56,"armGroupLabels":57,"otherNames":23},"Each participant in the placebo group takes matching placebo.",[43],[59],{"name":60,"affiliation":61,"role":62},"Xin Zheng, MD,PhD","Chinese Academy of Medical Sciences, Fuwai Hospital","PRINCIPAL_INVESTIGATOR",[64],{"name":60,"role":65,"phone":66,"phoneExt":23,"email":67},"CONTACT","+86 13681077247","zhengxin@fuwai.com",[69,85],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Fuwai Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100037","China","CN",{"type":78,"coordinates":79},"Point",[80,81],116.39723,39.9075,{"lat":81,"lon":80},[84],{"name":60,"role":65,"phone":66,"phoneExt":23,"email":67},{"facility":86,"status":71,"city":87,"state":88,"zip":89,"country":75,"countryCode":76,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Fuwai Hospital Chinese Academy of Medial Sciences, Shenzhen","Shenzhen","Guangdong","518038",{"type":78,"coordinates":91},[92,93],114.0683,22.54554,{"lat":93,"lon":92},[96],{"name":97,"role":65,"phone":98,"phoneExt":23,"email":99},"Wenyu Guo, MD,PhD","15813833652","405514738@qq.com",{"type":101,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100520352",false,"NCT06055452","Effects of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension","Effects and Mechanism of SGLT2 Inhibitors in Pre-heart Failure Populations With Hypertension","Inclusion Criteria:\n\n• Meeting all the following criteria:\n\n1. Aged 18 years and above.\n2. Hypertensive patients currently taking at least one antihypertensive medication as recommended by guidelines, and blood pressure is within the target range (\\\u003C140\u002F90 mmHg).\n3. Within 3 months prior to screening，result meet any of the following criteria:\n\n   1. Left atrial volume index \\> 34 mL\u002Fm² measured by echocardiography;\n   2. Average E\u002Fe' \\> 9 measured by echocardiography;\n   3. NT-proBNP \\> 125 ng\u002Fml.\n4. Signing an informed consent form.\n\nExclusion Criteria:\n\n* • Exclusion criteria include any of the following conditions:\n\n  1. History of diabetes.\n  2. History of heart failure.\n  3. History of myocardial infarction, acute coronary syndrome within the past 6 months, or planned coronary revascularization within the next 6 months\n  4. Left ventricular systolic dysfunction, defined as LVEF \\\u003C 50%.\n  5. Systolic blood pressure \\\u003C 100 mmHg.\n  6. A history of arrhythmias such as atrial fibrillation, atrial flutter, frequent atrial premature contractions, and frequent ventricular premature contractions may impact the structural and functional aspects of the heart.\n  7. Moderate and above valvular heart disease.\n  8. Severe obstructive disease of the left ventricular outflow tract, including aortic valve stenosis.\n  9. Confirmed diagnosis of cardiomyopathy and infiltrative myocardial diseases.\n  10. Visited within the past 1 month due to Genitourinary tract infection.\n  11. Chronic kidney disease or estimated Glomerular Filtration Rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m².\n  12. Alanine aminotransferase or aspartate aminotransferase levels \\> 3 times the upper limit of normal.\n  13. Contraindications to taking SGLT2 inhibitors.\n  14. Currently taking SGLT2 inhibitors, SGLT-1\u002F2 inhibitors, or other antihyperglycemic medications (including metformin, glucagon-like peptide-1 receptor agonists, etc.).\n  15. Pregnancy or planning pregnant, or currently breastfeeding.\n  16. Malignant tumors or other severe illnesses with a life expectancy of less than 3 years.\n  17. History of alcohol abuse or substance abuse within the past year.\n  18. Mental disorders or communication barriers, cognitive impairments, or other severe illnesses that may affect participation in the study.\n  19. Participation in or currently participating in other clinical trials within the last 3 months.\n  20. Known poor compliance with study follow-up or study drug.\n  21. Any condition or contraindication that makes a person intolerant to magnetic resonance imaging (MRI) or contraindicates MRI examination, such as the presence of implanted intracranial aneurysm clips, cardiac pacemakers or defibrillators, insulin pumps, etc.","ALL","18 Years",{"count":111,"type":112},120,"ESTIMATED","INTERVENTIONAL",[115],"PHASE4","In this multicenter, randomized, placebo-controlled trial in pre-heat failure patients with hypertension and without diabetes, we will enroll 120 eligible patients to randomized to receive placebo or engagliflozin (10mg\u002Fd) for follow them for 6 months. The primary endpoint is the left atrial volume index, which reflects left ventricular diastolic function. We sought to comprehensively evaluate the effect of engagliflozin on the structure and function and explore its underlying mechanisms.",[118,119],"Pre-Heart Failure","Hypertension",[118,119,121,38],"Randomized controlled trial","2026-03-04",{"date":124,"type":125},"2026-03-05","ACTUAL",{"date":127,"type":125},"2024-01-19",{"date":129,"type":112},"2026-12-31",{"name":5,"class":6},2]