[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Subodh Verma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,72],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641637","phase-3-baxdrostat-and-ventricular-remodeling-100641637",false,"NCT07655362","Baxdrostat and Ventricular Remodeling","A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Baxdrostat on Ventricular Remodeling","BaxREMODEL","INCLUSION CRITERIA\n\n1. Individuals ≥18 years of age who are willing and able to provide signed informed consent\n2. History of hypertension (Systolic BP \\>140 and \\\u003C170 mmHg)\n3. Serum K+ ≥3.5 and \\\u003C5.0 mmol\u002FL at Screening\n4. Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:\n\n   * Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n   * Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm\n   * Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female \\>95 g⁄m\\^2 or Male \\>115 g⁄m\\^2\n   * LVMi by cMRI: Female \\>68 g⁄m\\^2 or Male \\>85 g⁄m\\^2\n5. The presence of ≥1 of the following risk factors:\n\n   * Documented type 2 diabetes mellitus or a glycated hemoglobin (A1C) level ≥6.5%\n   * Estimated glomerular filtration rate (eGFR) 45-60 mL\u002Fmin\u002F1.73m\\^2 at Screening\n   * Urine albumin-creatinine ratio (UACR) ≥3 mg\u002Fmmol\n   * IVS ≥1.4 cm\n   * PW ≥1.4 cm\n   * LVMi ≥105 g⁄m\\^2 for female and ≥125 g⁄m\\^2 for male individuals (by echocardiography)\n   * History of HFpEF (LV ejection fraction ≥50%)\n   * NT-proBNP ≥125 pg\u002FmL (within past 6 months)\n6. Female individuals who are of childbearing age can only be considered eligible if:\n\n   * they are postmenopausal (amenorrhoeic for ≥12 months following cessation of exogenous hormonal treatment) or have had a surgical procedure (eg. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) ≥6 months at Screening that prevents them from becoming pregnant or\n   * the result of their pregnancy test at the baseline visit is negative, and they agree to use at least one highly effective and one effective contraception method to avoid pregnancy during the 30 days before randomization, throughout the research study, and for at least 30 days after taking the last dose of the assigned IP\n\nEXCLUSION\n\n1. Considered unsuitable by the investigator for any reason that may either place the participant at increased risk during participation or interfere with the interpretation of the study outcomes\n2. Female individuals who are pregnant, or can get pregnant, are breast-feeding or are planning to breastfeed and are\u002Fwill not be using at least one highly effective contraception method (see Inclusion Criteria section for definitions) during the 30 days before Randomization, throughout the research study, and for at least 30 days after taking the last dose of the assigned IP\n3. Upper arm circumference \\\u003C18 cm or \\>43 cm at Screening\n4. Body mass index \\>40 kg\u002Fm\\^2 (Image quality and accurate assessment of cardiac function degrades with obesity across all imaging modalities. Although CMR-derived images are the least compromised by high body mass indexes, MRI bore sizes and table weight limits, greater safety risks \\[eg. thermal burns\\] as well as increased frequencies of claustrophobia remain major challenges.\n5. Contraindication or inability to undergo CMR scan\n6. Serum Na+ level \\\u003C135 mmol\u002FL at Screening\n7. A1C \\>10% if living with T2DM during the 30 days before Randomization\n8. At Screening\n\n   * Systolic BP ≤120 mmHg\n   * Heart rate \\>110 or \\\u003C45 bpm per electrocardiogram (ECG) performed at Screening\n   * eGFR \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 at Screening\n   * New York Heart Association (NYHA) functional HF class IV\n9. At Screening or first IP intake\n\n   * White blood cell (WBC) count \\>15 X 10\\^9\u002FL or absolute neutrophil count \\\u003C1 X 10\\^9\u002FL\n   * Hemoglobin (Hb) \\\u003C100 g\u002FL and\u002For anticipated initiation of erythropoietin-stimulating agents and\u002For planned transfusion within 60 days after screening\n   * Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>3X upper limits of normal (ULN) with a corresponding bilirubin \\>34 μmol\u002FL unless the potential participant has a history of Gilbert syndrome\n10. Medical history\n\n    * Planned dialysis or kidney transplant during this research study\n    * Adrenal insufficiency\n    * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease\n    * Secondary causes of hypertension eg. Cushing's syndrome, aortic coarctation, renal artery stenosis, uncontrolled hyperthyroidism, untreated hyperthyroidism, hypothyroidism or pheochromocytoma\n    * HF due to infiltrative cardiomyopathy (eg. sarcoid, amyloid), arrhythmogenic right ventricular (RV) cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease\n    * Acute coronary syndrome, myocardial infarction, stroke, unstable angina pectoris, hypertensive encephalopathy, transient ischemic attack, or hospitalization for HF, during the 30 days before Screening\n    * Persistent atrial fibrillation, left bundle branch block or any cardiac arrhythmia requiring treatment\n    * Severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history\n    * Clinical evidence of, or suspicion of, active infection (at the discretion of the Site Investigator)\n11. Surgical history\n\n    * Undergone a major cardiovascular surgical procedure (eg. percutaneous coronary intervention\u002Fcoronary artery bypass grafting or percutaneous coronary\n    * Intervention\u002Fcoronary artery bypass grafting) or major endoscopic procedure (thoracoscopic or laparoscopic) during the 60 days before Randomization\n    * Previous or planned coronary, carotid, or peripheral artery revascularization during the 45 days before Screening\n    * Prior solid organ transplant and\u002For cell transplants\n    * Previous cardiac device implant (eg. implantable cardioverter defibrillator\u002Fcardiac resynchronization therapy\u002Fpacemaker) or planned device implant ≤90 days after screening\n12. Prior treatment (within 30 days before Screening) with or currently on an angiotensin-receptor blocker (ARB) in combination with an angiotensin converting enzyme inhibitor (ACEi)\n13. Prior treatment (within 30 days before Screening) with or currently on a mineralocorticoid receptor antagonist (MRA) or a K+-sparing diuretic, or anticipated initiation of either of these agents during the study period\n14. Unwilling to discontinue taking K+ supplements\n15. On K+ binders within 30 days prior to Screening\n16. On or expected to initiate a strong cytochrome P450 3A (CYP3A) inducer (eg. carbamazepine, enzalutamide, mitotane, phenytoin, rifabutin, rifampin and St. John's wort)\n17. Prior treatment within 6 months prior to Screening with a cytotoxic therapy (eg. cisplatin, doxorubicin, etoposide, misoprostol, trastuzumab)\n18. Known hypersensitivity to baxdrostat or drugs of the same class or any of its excipients\n19. Participation in another clinical study involving the investigational drug within 30 days prior to Screening or has plans to participate in another clinical study within 30 days of discontinuing the investigational drug","ALL","18 Years",{"count":20,"type":21},286,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this trial is to learn whether adding the blood pressure medication baxdrostat (Baxfendy) to standard-of-care medical therapies will beneficially change the heart structure and function of adults who have high blood pressure, thickened left heart walls, and are at risk for heart or kidney disease.\n\nTo determine if baxdrostat improves heart structure and function, the participants will:\n\n* take a baxdrostat or a placebo (a look-alike tablet that contains no drug) tablet once a day for 12 months\n* undergo a safe and non-invasive cardiac magnetic resonance imaging scan (to measure heart mass, stiffness and function) at the beginning of the study and 12 months later\n* visit the clinic for checkups and blood or urine tests 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after taking the first tablet",[27],"Cardiac Remodeling",[29,30,31,32,33,34],"Baxdrostat","Left Ventricle Remodeling","Double-blind","Randomized","Multicentre","Cardiorenal","NOT_YET_RECRUITING","2026-06-12",{"date":38,"type":39},"2026-06-17","ACTUAL",{"date":41,"type":21},"2026-06-30",{"date":43,"type":21},"2028-12-31",{"name":45,"class":46},"Subodh Verma","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100613728","phase-3-finerenone-and-cardiac-remodeling-100613728","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.",{"count":57,"type":21},156,[24],"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",[61],"Heart Failure",[63,30,31,32,61,33,34],"Finerenone","2025-12-05",{"date":66,"type":39},"2025-12-08",{"date":68,"type":21},"2025-12",{"date":70,"type":21},"2030-12",{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100589503","phase-3-sglt2-inhibition-with-empagliflozin-in-fontan-circulatory-failure-100589503","NCT06955260","SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure","A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)","EMPA-HEART-3","Inclusion Criteria:\n\n* Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out daily life activities, on standard of care therapy\n\nExclusion Criteria:\n\n* Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial\n* Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors\n* Pregnant or planning a pregnancy during the duration of the trial or breast feeding\n* Living with type 1 diabetes mellitus\n* Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis)\n* History of ketoacidosis\n* Has an estimated glomerular filtration rate (eGFR) that is \\\u003C30 mL\u002Fmin\u002F1.73 m2 Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2-fold upper limit of normal (ULN) at screening\n* Has a baseline systolic BP that is \\\u003C80 mmHg or ≥200 mmHg\n* Planned hospital intervention during trial period for management of FCF defined as one of the following:\n* Admission for intravenous diuretics\n* Admission for intravenous inotropes\n* Admission for ascites drainage\n* Admission for new or worsening ascites of clinical significance\n* Admission for management of arrhythmia\n* Admission for management of lymphatic dysfunction\n* Admission for interventional cardiological or cardiac surgical procedure within 30-days prior to screening, or consideration for any cardiac surgical or interventional cardiological procedure during trial participation\n* Admission for cardiac resynchronization therapy within 90-days prior to screening, or consideration of cardiac resynchronization therapy during trial participation\n* Is unable to provide written informed consent, complete the trial or comply with the requirements of the trial protocol\n* Participation in other interventional studies within 30-days of the screening visit that could influence any of the trial outcomes (exclusive of observational registries)\n* Received intravenous diuretic within the previous 14-days\n* On a heart transplant waiting list\n* Current or imminent hospitalization for management of FCF",{"count":81,"type":21},410,[24],"Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life. FCF occurs when the single working heart ventricle is no longer strong enough to pump blood throughout the body. This also means the heart has difficulty supplying oxygen to keep up with the needs of the body. As a result, individuals living with FCF may have some challenges carrying out day to day activities. A heart transplant is currently the only therapeutic option for individuals living with FCF. The investigators are conducting this trial to determine whether a medication called empagliflozin can help these people have a better quality of life.",[85],"Congenital Heart Disease",[87,88,31,89],"Fontan Circulatory Failure","Empagliflozin","randomized","2025-04-24",{"date":92,"type":39},"2025-05-02",{"date":94,"type":21},"2025-05",{"date":96,"type":21},"2028-03",{"name":45,"class":46},1,""]