[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645175":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":77,"collaborators":26,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Heart Health Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Participants receive empagliflozin 10 mg oral tablet once daily plus finerenone 10 mg oral tablet once daily for 12 weeks. At Week 4 (visit 3, ±4 days), the finerenone dose may be up-titrated to 20 mg once daily if the following criteria are met: serum potassium ≤4.8 mmol\u002FL and estimated glomerular filtration rate (eGFR) decline \\\u003C30% from the previous visit's value.",[13],"Drug: Empagliflozin and Finerenone",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Participants receive matching placebo for empagliflozin 10 mg oral tablet once daily plus matching placebo for finerenone 10 mg oral tablet once daily for 12 weeks. To maintain blinding, a sham up-titration of the finerenone placebo is performed at Week 4 (visit 3, ±4 days) using the same criteria simulation.",[19],"Drug: Placebo for Empagliflozin and Finerenone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Empagliflozin and Finerenone","This is a fixed-dose combination of two oral medications-empagliflozin (a sodium-glucose cotransporter 2 inhibitor) and finerenone (a nonsteroidal mineralocorticoid receptor antagonist)-administered simultaneously as separate tablets once daily for 12 weeks. The intervention consists of empagliflozin 10 mg once daily plus finerenone 10 mg once daily, taken orally in the morning with or without food.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo for Empagliflozin and Finerenone","Participants receive two matching placebo tablets orally once daily in the morning, with or without food, for 12 weeks: one placebo matching empagliflozin 10 mg and one placebo matching finerenone 10 mg. Both placebos are identical in appearance, size, shape, color, and taste to the corresponding active study drugs to ensure complete double-blinding.",[15],[32],{"name":33,"affiliation":34,"role":35},"Xin Du","Beijing Anzhen Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Xin Du, Professor","CONTACT","+8613370103558","duxinheart@sina.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Rong Han","+86 13910669903","hanrong@hhresearch.cn",[47,63],{"facility":48,"status":26,"city":49,"state":50,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Beijing Anzhen Hospital, Capital Medical University","Beijing","Beijing Municipality","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60,62],{"name":33,"role":39,"phone":61,"phoneExt":26,"email":41},"+86 13370103558",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":64,"status":26,"city":65,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Ruyang County People's Hospital","Luoyang",{"type":54,"coordinates":67},[68,69],112.43684,34.67345,{"lat":69,"lon":68},[72,76],{"name":73,"role":39,"phone":74,"phoneExt":26,"email":75},"Wukun Ma","+86 13183087920","646242109@qq.com",{"name":73,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":78,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100645175","finerenone-and-empagliflozin-combination-in-obesity-with-hypertension-a-12-week-prospective-parallel-design-double-blind-randomized-placebo-controlled-trial-100645175",false,"NCT07678151","Finerenone and Empagliflozin Combination in Obesity With Hypertension: A 12-Week Prospective, Parallel-design, Double-blind, Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\nAge ≥ 40 years.\n\nBody mass index (BMI) ≥ 28 kg\u002Fm² or abdominal obesity, defined as meeting any of the following:\n\nWaist circumference ≥ 90 cm (male) or ≥ 85 cm (female); Waist-to-hip ratio ≥ 0.9 (male) or ≥ 0.85 (female); Waist-to-height ratio ≥ 0.5. Unattended office systolic blood pressure (SBP) ≥ 140 mmHg and \\\u003C 160 mmHg during the screening period (within 1 week before randomization).\n\nCurrently taking no more than 2 antihypertensive agents (fixed-dose combinations are counted by the number of active ingredients).\n\nNo changes in the type or dose of antihypertensive medications within 4 weeks before the screening visit.\n\nProvide written informed consent.\n\nExclusion Criteria:\n\nDiastolic blood pressure ≥ 100 mmHg. Diagnosed diabetes mellitus or fasting plasma glucose ≥ 7.0 mmol\u002FL. History of heart failure (any ejection fraction) or left ventricular ejection fraction \\\u003C 50%.\n\nAcute coronary syndrome, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) within 90 days.\n\nStroke or transient ischemic attack (TIA) within 90 days. Known secondary hypertension (e.g., bilateral renal artery stenosis \\>75%, aldosteronism, pheochromocytoma), except documented sleep apnea.\n\nSevere hepatic dysfunction (AST\u002FALT \\> 3× upper limit of normal, or Child-Pugh class C).\n\nAcute kidney injury within 6 months before screening, or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m², or kidney transplant (or planned).\n\nPrimary adrenal insufficiency (Addison's disease). Contraindications to any component of the study drugs (e.g., urinary tract infection within 90 days, serum potassium \\> 5.0 mmol\u002FL, drug allergy).\n\nMajor surgery under general anesthesia within 90 days before screening, or elective surgery planned within 90 days after screening.\n\nGastrointestinal surgery or disease that, in the investigator's judgment, may affect absorption of the study drug.\n\nPregnancy, lactation, or planned pregnancy (for both male and female participants) during the study period.\n\nActive malignancy. Life expectancy \\\u003C 3 months. Use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) or inducers (e.g., rifampicin, carbamazepine, phenytoin) that cannot be discontinued within 7 days before Day 1.\n\nUse of mineralocorticoid receptor antagonists (e.g., finerenone, eplerenone, spironolactone), renin inhibitors, SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), or SGLT-1\u002F2 inhibitors (e.g., canagliflozin) within 8 weeks before screening or during the intervention period.\n\nUse of potassium supplements, potassium-sparing diuretics (e.g., amiloride, triamterene), or potassium-binding agents within 8 weeks before screening or during the intervention period.\n\nParticipation in a clinical trial of empagliflozin or finerenone within 1 month before screening.\n\nCurrent use of weight-loss medications (e.g., GLP-1 receptor agonists, GIP\u002FGLP-1 dual agonists, GLP-1\u002FGCGR dual agonists) or prior\u002Fplanned bariatric surgery.\n\nKnown or suspected orthostatic hypotension or autonomic dysfunction. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.","ALL","40 Years",{"count":88,"type":89},260,"ESTIMATED","INTERVENTIONAL",[92],"NA","The EFFORT Study (Empagliflozin and Finerenone Combination in Obesity with Hypertension) is a 12-week, randomized, double-blind, placebo-controlled trial that aims to test whether combining empagliflozin (10 mg\u002Fday) with finerenone (10 mg\u002Fday, up-titrated to 20 mg after 4 weeks) can significantly lower office systolic blood pressure in adults with obesity and stage 1 hypertension (systolic BP 140-160 mmHg) who are on up to two stable antihypertensives. The study will enroll 260 participants from community settings. Beyond blood pressure, the trial will also assess effects on diastolic pressure, cumulative BP exposure, urinary albumin-to-creatinine ratio, inflammation (hs-CRP), fasting glucose, body weight, and quality of life. Safety monitoring focuses on hyperkalemia, acute kidney injury, hypotension, and hypoglycemia. If positive, this research may offer a new, mechanism-based therapeutic strategy for the growing population with cardiometabolic risk, potentially providing better cardiovascular and kidney protection than conventional approaches.",[95],"Hypertension (HTN)",[97,98,99,100],"Sodium-Glucose Transporter 2 Inhibitors","Mineralocorticoid Receptor Antagonists","Blood Pressure","Obesity","NOT_YET_RECRUITING","2026-06-25",{"date":104,"type":105},"2026-07-01","ACTUAL",{"date":107,"type":89},"2026-07-13",{"date":109,"type":89},"2027-08-31",{"name":5,"class":6},2]