[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Juntendo University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100469434","phase-3-early-treatment-with-a-sodium-glucose-co-transporter-2-inhibitor-in-high-risk-patients-with-acute-heart-failure-100469434",false,"NCT05392764","Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Empagliflozin in Patients With Acute Heart Failure","EMPA-AHF","Inclusion Criteria:\n\nPatients who meet the below inclusion criteria will be randomized within 12 h after presentation to the hospital\n\n1. Age of ≥20\\*\n2. Hospitalized with a diagnosis of acute heart failure, requiring intravenous loop diuretic therapy, and with all of the following characteristics:\n\n   i. Dyspnoea at rest or induced by slight exertion ii. At least two of the following findings: jugular venous distention, pulmonary rales, lower leg edema, and pulmonary congestion on chest X-ray iii. If the patient has a sinus rhythm at the time of admission, BNP ≥350 pg\u002FmL or NT-proBNP ≥1400 pg\u002FmL; if the patient has atrial fibrillation at the time of admission, BNP ≥500 pg\u002FmL or NT-proBNP ≥2000 pg\u002FmL. For patients taking an angiotensin receptor neprilysin inhibitor, only the reference value for NT-proBNP will be applicable.\n3. At least one of the following characteristics:\n\n   i. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2, as calculated using the CKD Epidemiology Collaboration for JapaneseModification of Diet in Renal Disease formula ii. Already taking ≥40 mg of oral furosemide during the period before hospitalization. For patients on loop diuretics other than furosemide, the following conversion should be used: oral furosemide 20 mg = oral azosemide 30 mg = oral torasemide 5 mg.\n\n   iii. Urine output of \\\u003C300 mL during the 2 h following an appropriate dose of intravenous furosemide administered after hospitalization. An appropriate dose of intravenous furosemide is 20 mg for patients who have not been taking furosemide regularly before hospitalization and is the same as, or greater than, the daily oral dose for patients who have been taking furosemide regularly before hospitalization.\n4. Provided written consent to participate in the study \\*If the patient is 90 years of age or older and cognitive decline is considered necessary, Mini-Cog should be used to confirm that its score is not less than 3.\n\nExclusion Criteria:\n\n1. eGFR \\\u003C20 mL\u002Fmin\u002F1.73m2 at the time of admission\n2. Already taking an SGLT2i within 3 months prior to hospitalization\n3. Type 1 diabetes mellitus\n4. Systolic blood pressure \\\u003C90 mmHg\n5. Expected to newly require treatment with thiazide, tolvaptan, or carperitide within 48 hours of study drug administration\n6. Main cause of acute heart failure hospitalization is not fluid retention (e.g., persistent ventricular tachycardia, persistent atrial fibrillation\u002Fatrial flutter with a ventricular response rate of ≥130 bpm, persistent bradycardia with a ventricular response rate of \\\u003C45 bpm, an infection, severe anemia, and an acute exacerbation of COPD)\n7. Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization.\n8. At risk of ketoacidosis or hyperosmolar hyperglycaemia\n9. On dialysis, including peritoneal dialysis, or the initiation of dialysis during hospitalization is planned\n10. Pregnant or lactating women\n11. Underwent the following therapeutic interventions within 30 days: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge-to-edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, cardiac resynchronization therapy defibrillator, or implantable ventricular-assist device\n12. A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days\n13. Ventricular tachycardia with syncope within 90 days\n14. Heart transplant recipient or listed for heart transplantation and expected to undergo transplantation during the present treatment; implanted with an implantable ventricular-assist device or expected to require an implantable ventricular-assist device during the present treatment; or expected to switch to palliative care\n15. Intubated at the time of screening or expected to require intubation within within 48 hours of study drug administration\n16. Severe valvular heart disease expected to be treated with thoracostomy or catheterization (a reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function does not exist, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)\n17. A diagnosis of secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry disease, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), or pericardial constriction.\n18. A diagnosis of peripartum cardiomyopathy made within 6 months\n19. Active myocarditis\n20. Presence of uncontrolled thyroid disease\n21. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae)\n22. Symptomatic bradycardia or complete atrioventricular block, being treated with a temporary pacemaker implantation at the time of admission, or expected to require a temporary pacemaker implantation in the future. Patients who have already been treated with a permanent pacemaker implantation do not meet the exclusion criteria.\n23. Serious liver disorder (an increase in AST, ALT, or ALP level ≥3 times the upper limit of normal) or cirrhosis with varices or other findings suggestive of portal hypertension\n24. Alcohol use disorder of at least mild severity according to the DSM-V\n25. A diagnosis of active malignancy or suspected active malignancy made within 2 years\n26. Coexisting diseases other than heart failure with an expected survival prognosis of ≤1 year\n27. Participation in a clinical study of another drug 30 days before hospitalization\n28. Patients considered to require fasting at screening.\n29. Other conditions likely to interfere with the patient's safety or compliance with the protocol\n30. Other patients who are considered unsuitable by the principal investigator or other investigators","ALL","20 Years",{"count":20,"type":21},444,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The EMPA-AHF trial is a multicentre, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of early initiation of once-daily oral empagliflozin 10 mg in patients hospitalized for patients with acute heart failure (AHF) who are at a high risk of adverse events.",[27],"Acute Heart Failure","RECRUITING","2026-02-11",{"date":31,"type":32},"2026-02-13","ACTUAL",{"date":34,"type":32},"2022-09-10",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Juntendo University","OTHER",69,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100623516","phase-4-efficacy-and-safety-with-early-treatment-of-finerenone-in-hospitalized-patients-with-heart-failure-100623516","NCT07397650","Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure","FACILITATE-HF","Patients eligible for inclusion in this study meet all of the following criteria: \\\u003Cbr\\>Inclusion Criteria:\n\n1. Patients ≥18 years of age, male or female\\\u003Cbr\\>\n2. Current hospitalization with AHF requiring intravenous loop diuretics or vasodilators during the index admission\\\u003Cbr\\>\n3. Patients have to have at least one of new or worsening symptoms due to HF and one of new or worsening physical examination findings due to HF \\\u003Cbr\\> (i) symptom\\\u003Cbr\\> dyspnoea, decreased exercise tolerance, or fatigue\\\u003Cbr\\> (ii) physical examination\\\u003Cbr\\> peripheral edema, increasing abdominal distention or ascites, pulmonary rales\u002Fcrackles\u002Fcrepitations, increased jugular venous pressure and\u002For hepatojugular reflux, S3 gallop, clinically significant or rapid weight gain\\\u003Cbr\\>\n4. Patients who are not hemodynamically unstable as defined by meeting the following criteria\\\u003Cbr\\>\n\n   1. Systolic blood pressure ≥100 mmHg and no symptoms of hypotension within 6 hours prior to randomization\\\u003Cbr\\>\n   2. No increase in intravenous diuretic dose or intravenous vasodilators within 6 hours prior to randomization with worsening HF symptom\\\u003Cbr\\>\n   3. Without cardiogenic shock, no use of inotropes or vasopressors, no use of mechanical circulatory support, not requiring intubation after admission, and not expected to require inotropes, vasopressors, mechanical circulatory support or intubation during the index hospitalization\\\u003Cbr\\>\n5. NTproBNP ≥1500 pg\u002FmL or BNP ≥375 pg\u002FmL (For patients treated with ARNI in the previous 4 weeks prior to randomization, only NT-proBNP values should be used)\\\u003Cbr\\>\n6. Most recent LVEF ≥40% within the past 1 year \\\u003Cbr\\>\n7. Randomization within 24 hours after admission, and drug administration within 36 hours after admission \\\u003Cbr\\>\n8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\\\u003Cbr\\>\n9. Signed informed consent must be obtained prior to participation in the study\\\u003Cbr\\>\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C25 mL\u002Fmin\u002F1.73m2 by CKD-EPI Creatinine Equation (2021) at screening\\\u003Cbr\\>\n2. Serum\u002Fplasma potassium \\>5.0 mmol\u002FL at screening\\\u003Cbr\\>\n3. Patients who cannot receive oral treatment\\\u003Cbr\\>\n4. Use of eplerenone, spironolactone, esaxerenone or potassium-sparing diuretic within 30 days before randomization \\\u003Cbr\\>\n5. Known hypersensitivity to the study intervention (active substance or excipients)\\\u003Cbr\\>\n6. Systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers within 7 days before randomization or is expected to be used during the study period (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin).\\\u003Cbr\\>\n7. Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI) simultaneously\\\u003Cbr\\>\n8. Acute heart failure in which other diseases are the main cause of symptoms and signs (chronic obstructive pulmonary disease, anemia, etc.)\\\u003Cbr\\>\n9. Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during the study period\\\u003Cbr\\>\n10. Pregnant or lactating female\\\u003Cbr\\>\n11. Acute coronary syndrome, pulmonary thromboembolism, stroke, or transient ischemic attack within 90 days before randomization.\\\u003Cbr\\>\n12. Have undergone the following therapeutic intervention within 30 days before randomization: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease, transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge-to-edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, or a cardiac resynchronization therapy defibrillator.\\\u003Cbr\\>\n13. Heart transplant recipients or patients listed for heart transplantation who are expected to undergo transplantation during the study, patients implanted with an implantable ventricular-assist device, patients expected to require an implantable ventricular-assist device during the study, and patients expected to switch to palliative care during the study.\\\u003Cbr\\>\n14. Coronary or valvular heart disease likely to require surgical or percutaneous intervention within the study period (there is no reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)\\\u003Cbr\\>\n15. Secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, chemotherapy induced cardiomyopathy, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), pericardial constriction, right heart failure in absence of left-sided structural disease\\\u003Cbr\\>\n16. Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae and infective endocarditis)\\\u003Cbr\\>\n17. Peripartum cardiomyopathy diagnosed within 6 months before randomization.\\\u003Cbr\\>\n18. Active myocarditis at randomization.\\\u003Cbr\\>\n19. Patients with symptomatic bradycardia or complete atrioventricular block who are being treated with temporary pacemaker implantation at the time of admission, or who are expected to require temporary or permanent pacemaker implantation in the future. Patients who have already been treated with permanent pacemaker implantation do not meet the exclusion criteria\\\u003Cbr\\>\n20. Presence of uncontrolled thyroid disease\\\u003Cbr\\>\n21. Addison's disease\\\u003Cbr\\>\n22. Hepatic insufficiency classified as Child-Pugh C \\\u003Cbr\\>\n23. Patients with excessive alcohol intake (15+ drinks\u002Fweek for men, 8+ drinks\u002Fweek for women)\\\u003Cbr\\>\n24. Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)\\\u003Cbr\\>\n25. Patients with dementia. If a sub-investigator determines that confirmation of cognitive impairment is necessary, it must be verified that the Mini-Cog score is not less than 4.\\\u003Cbr\\>\n26. Participation in another interventional clinical study (e.g. phase 1 to 3 clinical studies) or treatment with another investigational medicinal product within 30 days prior to randomization.Other conditions likely to interfere with the patient's safety or compliance with the protocol\\\u003Cbr\\>\n27. Patients deemed unsuitable by the principal investigator or sub investigator","18 Years",{"count":50,"type":21},550,[52],"PHASE4","FACILITATE-HF is a multicenter, randomized, double-blind, placebo-controlled trial designed to determine whether initiation of finerenone during the early phase of hospitalization has beneficial effects in patients with AHF who have left ventricular ejection fraction 40% or more.",[27],"2026-02-08",{"date":29,"type":32},{"date":58,"type":21},"2026-02",{"date":60,"type":21},"2028-09-30",{"name":38,"class":39},21,""]