[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-pediatric\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-pediatric":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100607776","phase-3-a-study-to-learn-more-about-how-safe-finerenone-is-when-it-is-taken-for-a-longer-time-with-standard-treatment-in-children-and-young-adults-with-heart-failure-and-left-ventricular-systolic-dysfunction-100607776",false,"NCT07192952","A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction","A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)","FIORELLO","Inclusion Criteria:\n\n* For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE.\n* For newly enrolled infants \\\u003C6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.\n* For newly enrolled infants \\\u003C6 months of age: Elevated NT-pro BNP levels (\\> 500 mg\u002FL) at screening.\n* For newly enrolled infants \\\u003C6 months of age: Heart failure (HF) etiologies include congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial\u002Finherited and\u002For genetic CM; history of myocarditis (diagnosis of an acute episode at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction.\n* For newly enrolled infants \\\u003C6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).\n* Newly enrolled newborns and infants \\\u003C 6 months of age must have a body weight of ≥3 kg at Visit 1.\n\nExclusion Criteria:\n\n* For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \\>5.5 mmol\u002FL. After unblinding:\n\n  * For participants who received finerenone in FIORE: K+ \\>5.5 mmol\u002F L\n  * For participants who received placebo in FIORE: K+ \\>5.0 mmol\u002FL for children ≥2 years of age, and \\>5.3 mmol\u002FL for children \\\u003C2 years of age (if eGFR is \\\u003C60 mL\u002Fmin\u002F1.73m² for participants \\\u003C2 years of age, the serum potassium threshold of \\>5.0 mmol\u002FL will be used for exclusion)\n* For newly enrolled newborns and infants \\\u003C 6 months of age: Potassium ≥ 5.3 mmol\u002Fl (if eGFR is \\\u003C60 mL\u002Fmin\u002F1.73m², the serum potassium threshold of \\>5.0 mmol\u002FL will be used for exclusion).\n* For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m² at FIORE EoT or Visit 1.\n* For newly enrolled infants \\\u003C 6 months of age: Severe renal dysfunction with eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2 at screening or Visit 1.\n* Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1.\n* Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment.","ALL","18 Years",{"count":20,"type":21},117,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth.\n\nThe study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively.\n\nThe main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD.\n\nTo understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as \"treatment emergent adverse events\" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR).\n\nIn this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study.\n\nThe participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \\\u003C6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will:\n\n* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured\n* have blood samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer\n* for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback.\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health a month after the participants take their last treatment.",[27,28],"Left Ventricular Systolic Dysfunction","Heart Failure (Pediatric)","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2026-06-01",{"date":37,"type":21},"2030-12-30",{"name":39,"class":40},"Bayer","INDUSTRY",132,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100607457","phase-3-a-study-to-learn-more-about-how-well-finerenone-works-how-safe-it-is-and-how-it-moves-into-through-and-out-of-the-body-compared-to-placebo-when-taken-with-standard-treatment-in-children-with-heart-failure-and-left-ventricular-systolic-dysfunction-100607457","NCT07188805","A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Investigate the Efficacy, Safety, and PK\u002F PD of Finerenone, in Addition to Standard-of-care, in Pediatric Patients, 6 Months to \u003C 18 Years of Age With Heart Failure (HF) and Left Ventricular Systolic Dysfunction (LVSD)","FIORE","Inclusion Criteria:\n\n* Participants must be 6 months to \\\u003C18 years old at the time when the informed consent\u002Fassent is signed.\n* Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.\n* Elevated NT-pro BNP levels\n\n  * \\>500 ng\u002Fl for children ≥ 6 months to \\\u003C 2 years of age\n  * \\>300 ng\u002Fl, for children ≥ 2 years to \\\u003C18 years\n* Heart failure etiologies including congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial\u002Finherited and\u002For genetic CM; history of myocarditis (diagnosis of an acute episode was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure \\[HF\\]); LV noncompaction.\n* Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization.\n* Study participants must have a body weight ≥ 4.0 kg at Visit 1.\n\nExclusion Criteria:\n\n* Serum potassium:\n\n  * \\> 5.0 mmol\u002FL for children ≥ 2 years of age at either screening or randomization visit\n  * \\> 5.3 mmol\u002FL for children ≥ 6 months to \\\u003C 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73m², threshold of \\> 5.0 mmol\u002FL will be used)\n* Severe renal dysfunction with eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m² at screening or randomization visit.\n* Systolic blood pressure (SBP) \\\u003C 5th percentile for age, sex and height at screening or randomization.\n* Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization.\n* Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization.\n* Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization.\n* Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization.","6 Months","17 Years",{"count":53,"type":21},111,[24],"Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart is unable to pump enough blood to meet the body's needs. This can lead to symptoms like shortness of breath, fatigue, and poor growth in children.\n\nThe study treatment, finerenone (also called BAY94-8862), works by blocking a protein involved in inflammation, scarring, and thickening of the heart and blood vessels. This may help the heart to pump blood more effectively. This is the first study to explore its use specifically for children with heart failure and LVSD.\n\nThe main purpose of this study is to learn if finerenone works to help the heart compared to placebo in children with heart failure and LVSD. For this, the researchers will collect and analyze data on the levels of a protein called NT-proBNP in the blood, which indicates heart stress, and monitor the safety of the treatment.\n\nThe study will include children with heart failure and LVSD aged from 6 months to less than 18 years. The study participants will be randomly assigned to one of two treatment groups. Based on their group, they will receive either finerenone or a placebo for a duration of 3 months. A placebo looks like a treatment but does not have any medicine in it. Throughout the study, all participants will continue to receive their standard heart failure treatments.\n\nAt the start of this study, the doctors will check each participant's medical history and current medications. If participants qualify for the treatment phase, they will undergo treatment for about 90 days. During this time, they will visit the study site at least 3 times. During these visits, the participants will:\n\n* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured\n* have their heart examined by electrocardiogram (ECG) and echocardiogram\n* have blood samples taken\n* have physical examinations\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answers\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nAfter the initial three-month study, eligible participants will have the option to join a nine-month open-label extension study where all will receive finerenone. Participants who choose not to enroll in the extension will have a follow-up visit 30 days after their last treatment.",[27,28],"2026-06-12",{"date":59,"type":33},"2026-06-15",{"date":61,"type":33},"2025-11-19",{"date":63,"type":21},"2029-12-30",{"name":39,"class":40},133]