[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656838":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":42,"armGroups":50,"interventions":63,"overallOfficials":73,"centralContacts":78,"locations":42,"responsibleParty":84,"collaborators":42,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":42,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":42,"enrollmentInfo":97,"targetDuration":42,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":111,"whyStopped":42,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Change in left ventricular global longitudinal strain","Absolute change in left ventricular global longitudinal strain measured by speckle tracking echocardiography using QLAB 10.4 software from apical four-chamber views with three consecutive heart cycles greater than 61 frames per second. More negative values indicate better function","From baseline to 6 months",[14,17,21,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":12},"Change in left ventricular reservoir strain","Absolute change in left ventricular reservoir strain measured by speckle tracking echocardiography from baseline to 6 months",{"measure":18,"description":19,"timeFrame":20},"Number of participants with heart failure hospitalization","Number of participants who experience heart failure hospitalization","Up to 6 months",{"measure":22,"description":23,"timeFrame":20},"Number of participants with major adverse cardiovascular events","Number of participants with non-fatal myocardial infarction or ischemic stroke",{"measure":25,"description":26,"timeFrame":12},"Change in NT-proBNP level","Change in N-terminal pro B-type natriuretic peptide level in picograms per milliliter",{"measure":28,"description":29,"timeFrame":12},"Change in NYHA functional class","Change in New York Heart Association functional class score range 1 to 4 with higher scores indicating worse symptoms",{"measure":31,"description":32,"timeFrame":20},"Number of participants with dyspnea worsening","Number of participants with worsening of dyspnea assessed by five-point Likert scale score range 1 to 5 with higher scores indicating worse dyspnea",{"measure":34,"description":35,"timeFrame":20},"Number of participants with diuretic dose escalation","Number of participants who require diuretic dose escalation during the 6-month follow-up",{"measure":37,"description":38,"timeFrame":20},"Number of participants with hyperkalemia","Number of participants who develop hyperkalemia defined as serum potassium greater than 5.5 milliequivalents per liter",{"measure":40,"description":41,"timeFrame":20},"Number of participants with acute kidney injury","Number of participants who develop acute kidney injury defined as increase in serum creatinine greater than 0.3 milligrams per deciliter",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE","Overactivation of the mineralocorticoid receptor drives inflammation fibrosis and heart failure progression. Left ventricular global longitudinal strain measured by speckle tracking echocardiography is a sensitive marker for early myocardial remodeling. This is a prospective randomized parallel assignment study. Patients with HFpEF defined by HFA-PEFF score will be randomized to Finerenone plus standard of care or standard of care alone and followed for 6 months with clinical laboratory ECG and echocardiography assessment including speckle tracking at baseline and 6 months.",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"Finerenone plus Standard of Care","EXPERIMENTAL","Finerenone 10 mg once daily titrated to 20 mg once daily based on serum potassium and eGFR plus standard of care for HFpEF for 6 months",[56,57],"Drug: Finerenone","Other: Standard of care for HFpEF Description:",{"label":59,"type":60,"description":61,"interventionNames":62},"Standard of Care alone","ACTIVE_COMPARATOR","Standard of care for HFpEF according to 2022 AHA ACC HFSA guideline without Finerenone",[57],[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":42},"DRUG","Finerenone","Non-steroidal mineralocorticoid receptor antagonist 10 to 20 mg orally once daily for 6 months with monitoring of potassium creatinine and eGFR",[52],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":42},"Standard of care for HFpEF Description:","Standard of care for heart failure with preserved ejection fraction according to 2022 AHA ACC HFSA guideline including diuretics and guideline-directed medical therapy without Finerenone",[52,59],[74],{"name":75,"affiliation":76,"role":77},"Ahmed A Ahmed, prof","Cardiovascular Medicine Department, Assiut University Hospitals","STUDY_CHAIR",[79],{"name":80,"role":81,"phone":82,"phoneExt":42,"email":83},"Mostafa M Khairy, Resident","CONTACT","01145340851","Mostfa.elfraa@gmail.com",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Mostafa Mohamed Khairy","Resident Physician, Department of cardiovascular","100656838","phase-4-finerenone-and-cardiac-remodeling-in-hfpef-100656838",false,"NCT07830940","Finerenone and Cardiac Remodeling in HFpEF","Impact of Finerenone on Cardiac Remodeling and Heart Failure Progression in Patients With Heart Failure With Preserved Ejection Fraction The FIN-HF-LVS Registry","Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Clinically evidenced heart failure with left ventricular ejection fraction greater than or equal to 50 percent\n* HFA-PEFF score greater than or equal to 5 or score 2 to 4 with functional testing confirming HFpEF\n* Sinus rhythm on resting ECG at screening\n* Written informed consent\n\nExclusion Criteria:\n\n* Implanted cardiac pacemaker or defibrillator with active atrial pacing\n* Estimated glomerular filtration rate less than 25 milliliters per minute per 1.73 square meters\n* Baseline serum potassium greater than 5 milliequivalents per liter\n* Known hypersensitivity to Finerenone","ALL","18 Years",{"count":98,"type":99},194,"ESTIMATED","INTERVENTIONAL",[102],"PHASE4","This prospective randomized study aims to evaluate the efficacy of Finerenone as add-on therapy to standard of care compared to standard of care alone in preventing heart failure worsening and preserving cardiac function assessed by left ventricular strain in patients with heart failure with preserved ejection fraction.",[105],"Heart Failure With Preserved Ejection Fraction",[107,66,108,109,110],"Cardiac remodeling","HFpEF","Global longitudinal strain","Speckle tracking","NOT_YET_RECRUITING","2026-09-18",{"date":114,"type":115},"2026-09-22","ACTUAL",{"date":117,"type":99},"2026-09-20",{"date":119,"type":99},"2028-03-25",{"name":5,"class":6}]