[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613728":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":79,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":30,"enrollmentInfo":97,"targetDuration":30,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":112,"whyStopped":30,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Canadian Medical and Surgical Knowledge Translation Research Group","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone","ACTIVE_COMPARATOR","Active treatment group",[13],"Drug: Finerenone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Control treatment group",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will be allocated a starting dose of 10 or 20 mg of finerenone (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg finerenone",[9],[26],"Kerendia",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Participants will be allocated a starting dose of 10 or 20 mg of placebo (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg placebo",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Subodh Verma, MD, PhD","North York Diagnostic and Cardiac Centre","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":30,"email":40},"CONTACT","416-864-5997","subodh.verma@nydcc.ca",[42,60,66],{"facility":43,"status":30,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cambride Cardiac Care Centre","Cambridge","Ontario","N1R6V6","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-80.31269,43.3601,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":30,"email":59},"A Shekhar Pandey, MD","519-624-3511","pandey@cambridgecardiaccare.com",{"facility":34,"status":30,"city":61,"state":45,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":30,"geoPoint":30,"contacts":63},"North York","M6B3H7",[64],{"name":33,"role":38,"phone":65,"phoneExt":30,"email":40},"416-783-0000",{"facility":67,"status":30,"city":68,"state":45,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Diagnostic Assessment Centre","Toronto","M1S4N6",{"type":50,"coordinates":71},[72,73],-79.39864,43.70643,{"lat":73,"lon":72},[76],{"name":77,"role":38,"phone":78,"phoneExt":30,"email":40},"Verma Subodh, MD, PhD","416-291-7300",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Subodh Verma","Professor of Surgery and Pharmacology & Toxicology",[84],{"name":85,"class":86},"Bayer","INDUSTRY","100613728","phase-3-finerenone-and-cardiac-remodeling-100613728",false,"NCT07270367","Finerenone and Cardiac Remodeling","Finerenone and Cardiac Remodeling: A Randomized, Double- Blind, Placebo-Controlled Study to Evaluate The Effects of Finerenone on Ventricular Remodeling","FINE-MECH","Inclusion Criteria:\n\n* Individuals ≥18 years of age who are willing and able to provide signed informed consent\n* Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:\n\n  1. Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n  2. Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n  3. Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female \\>95 g⁄m\\^2 or Male \\>115 g⁄m\\^2\n  4. LVMi (with papillary muscles included in the LV blood pool) by cMRI: Female \\>59 g⁄m\\^2 or Male \\>75 g⁄m\\^2\n  5. LVMi (if the papillary muscles are included in the LVM) by cMRI: Female \\>68 g⁄m\\^2 or Male \\>85 g⁄m\\^2\n* The presence of at least one (≥1) of the following risk factors:\n\n  1. History of heart failure with preserved ejection fraction (left ventricular ejection fraction \\[LVEF\\] ≥50%);\n  2. Type 2 diabetes mellitus;\n  3. Estimated glomerular filtration rate (eGFR) ≥25 and \\\u003C75 mL\u002Fmin\u002F1.73 m\\^2;\n  4. Urine albumin-creatinine ratio (UACR) \\>3.39 mg\u002Fmmol and \\\u003C565 mg\u002Fmmol;\n  5. Left atrial volume indexed to baseline body surface area (LAVi) \\>40 mL\u002Fm\\^2 (by echocardiography and as measured by either the biplane area-length method or Simpson's biplane method);\n  6. IVS ≥1.4 cm;\n  7. PW ≥1.4 cm;\n  8. LVMi ≥125 g⁄m\\^2 for males and ≥105 g⁄m\\^2 for females (by echocardiography);\n  9. N-terminal pro-B-type natriuretic peptide (NT-proBNP; within past 6 months) ≥150 pg\u002FmL if in sinus rhythm or ≥450 pg\u002FmL if atrial fibrillation is present.\n  10. Females who are of childbearing age can only be included if I. they are postmenopausal (i.e. no menstruation for at least one \\[≥1\\] year) or have had a surgical procedure ≥6 months at screening that prevents them from becoming pregnant; or II. the result of their pregnancy test at the baseline visit is negative, and they agree to use medically acceptable contraception methods to avoid pregnancy for the duration of the trial and for 1 month after taking the last dose of the assigned investigational product.\n\nExclusion Criteria:\n\n* Females who are planning to become pregnant, are breastfeeding or are planning to breastfeed;\n* Males who are planning to either father a child or donate sperm for the duration of the trial and for 1 month after taking the last dose of the assigned IP;\n* Serum potassium level ≥5 mmol\u002FL at the time of screening;\n* eGFR \\\u003C25 mL\u002Fmin\u002F1.73 m\\^2 at the time of screening or on kidney replacement therapy;\n* UACR ≥565 mg\u002Fmmol at the time of screening;\n* Seated systolic blood pressure \\\u003C110 mmHg at the time of screening;\n* History of pulmonary arterial hypertension;\n* Type 1 diabetes mellitus;\n* Body mass index ≥40 kg\u002Fm\\^2;\n* Contraindication or inability to undergo MRI;\n* Known persistent hypoalbuminemia (≤30 g\u002FL on \\>1 measurement within last 6 months);\n* Currently on a mineralocorticoid receptor antagonist (MRA) or in the opinion of the investigator, an MRA is either clinically indicated or contraindicated (e.g. history of marked hyperkalemia, marked hemodynamic stress, intolerance to MRAs) - individuals who previously experienced gynecomastia with spironolactone may be eligible if they meet all the inclusion criteria and none of the exclusion criteria;\n* Requirement of any intravenous (IV) vasodilating drug (e.g. nitrates, nitroprusside), any IV natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) ≤24 hours prior to randomization;\n* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period;\n* History of cardiac device implant (e.g. implantable cardioverter defibrillator\u002Fcardiac resynchronization therapy\u002Fpacemaker) or planned device implant ≤90 days after screening;\n* Hospitalized for heart failure (HF) requiring initiation or change in HF therapy or an urgent visit for HF requiring IV diuretic therapy, either ≤45 days prior to screening;\n* LVEF \\\u003C40% per the most current echocardiogram or MRI;\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker;\n* History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, right HF in the absence of left-sided structural disease, pericardial constriction, hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis;\n* Myocardial infarction ≤45 days of screening;\n* Planned or previous cardiac surgery or major non-cardiac surgery ≤45 days of screening;\n* Planned or previous percutaneous coronary intervention ≤45 days of screening;\n* Stroke or transient ischemic stroke ≤90 days before randomization;\n* Severe valvular heart disease;\n* Addison's disease;\n* Individuals who are heart or kidney transplant recipients or who are (or are expected to be) listed for heart transplant, kidney dialysis or a kidney transplant ≤12 months of screening;\n* Any other known condition or therapy which would make the individual unsuitable for this trial (e.g. hepatic insufficiency, liver biomarkers \\>3X upper limit of normal, chronic pulmonary disease, life threatening arrhythmia, uncontrolled arrhythmia) or not allow participation for the full planned trial duration (e.g. active malignancy ≤24 months of screening or condition limiting life expectancy to \\\u003C12 months);\n* Allergy to finerenone (or its excipients);\n* Allergy to gadolinium;\n* Participation in an investigational study ≤15 days prior to screening, or during study.","ALL","18 Years",{"count":98,"type":99},156,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","The goal of this clinical trial is to learn if the drug finerenone (Karendia) can improve heart function in participants who are at risk for heart and kidney disease.\n\nThe main question it aims to answer is whether adding finerenone to standard-of-care heart failure medical therapies will beneficially alter the heart structure and function of people who have risk factors for heart and kidney complications and whose left side of the heart is enlarged.\n\nThe researchers will compare finerenone to a placebo (a look-alike substance that contains no drug) to see if finerenone improves heart structure and function.\n\nParticipants will:\n\n* take a finerenone or a placebo tablet once a day for 12 months\n* have a cardiac magnetic resonance imaging (cMRI; a safe, non-invasive scan to measure heart mass, stiffness and function) test at the beginning of the study and 12 months later\n* visit the clinic after one, three, six and twelve months to assess overall health and\u002For perform blood or urine tests",[105],"Heart Failure",[9,107,108,109,105,110,111],"Left Ventricle Remodeling","Double-blind","Randomized","Multicentre","Cardiorenal","NOT_YET_RECRUITING","2025-12-05",{"date":115,"type":116},"2025-12-08","ACTUAL",{"date":118,"type":99},"2025-12",{"date":120,"type":99},"2030-12",{"name":81,"class":6},3]