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Lund - Barnhjärtcentrum","Lund","Skåne County","222 41","Sweden","SE",{"type":37,"coordinates":1042},[1043,1044],13.19321,55.70584,{"lat":1044,"lon":1043},{"facility":1047,"status":30,"city":1048,"state":1049,"zip":1050,"country":1051,"countryCode":1052,"cosmosGeoPoint":1053,"geoPoint":1057,"contacts":20},"Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch","Guishan","Taoyuan","83301","Taiwan","TW",{"type":37,"coordinates":1054},[1055,1056],121.33672,24.99436,{"lat":1056,"lon":1055},{"facility":1059,"status":30,"city":1060,"state":20,"zip":1061,"country":1051,"countryCode":1052,"cosmosGeoPoint":1062,"geoPoint":1066,"contacts":20},"Kaohsiung Veterans General Hospital","Kaohsiung City","813414",{"type":37,"coordinates":1063},[1064,1065],120.31333,22.61626,{"lat":1065,"lon":1064},{"facility":1068,"status":1069,"city":1070,"state":20,"zip":1071,"country":1051,"countryCode":1052,"cosmosGeoPoint":1072,"geoPoint":1076,"contacts":20},"Taichung Veterans General Hospital","RECRUITING","Taichung","40705",{"type":37,"coordinates":1073},[1074,1075],120.6839,24.1469,{"lat":1075,"lon":1074},{"facility":1078,"status":30,"city":1079,"state":20,"zip":1080,"country":1051,"countryCode":1052,"cosmosGeoPoint":1081,"geoPoint":1085,"contacts":20},"National Cheng Kung University Hospital","Tainan","704",{"type":37,"coordinates":1082},[1083,1084],120.21333,22.99083,{"lat":1084,"lon":1083},{"facility":1087,"status":30,"city":1088,"state":20,"zip":1089,"country":1051,"countryCode":1052,"cosmosGeoPoint":1090,"geoPoint":1094,"contacts":20},"National Taiwan University Hospital","Taipei","100",{"type":37,"coordinates":1091},[1092,1093],121.52639,25.05306,{"lat":1093,"lon":1092},{"facility":1096,"status":30,"city":1088,"state":20,"zip":1097,"country":1051,"countryCode":1052,"cosmosGeoPoint":1098,"geoPoint":1100,"contacts":20},"MacKay Children's hospital","104217",{"type":37,"coordinates":1099},[1092,1093],{"lat":1093,"lon":1092},{"facility":1102,"status":30,"city":1103,"state":20,"zip":1104,"country":1105,"countryCode":20,"cosmosGeoPoint":1106,"geoPoint":1110,"contacts":20},"Cukurova Universitesi Tip Fakultesi Hastanesi","Adana","1330","Turkey (Türkiye)",{"type":37,"coordinates":1107},[1108,1109],35.32531,36.98615,{"lat":1109,"lon":1108},{"facility":1112,"status":30,"city":1113,"state":20,"zip":1114,"country":1105,"countryCode":20,"cosmosGeoPoint":1115,"geoPoint":1119,"contacts":20},"Hacettepe Universitesi Tip Fakultesi","Ankara","06230",{"type":37,"coordinates":1116},[1117,1118],32.85427,39.91987,{"lat":1118,"lon":1117},{"facility":1121,"status":30,"city":1122,"state":20,"zip":1123,"country":1105,"countryCode":20,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"Ankara Bilkent Sehir Hastanesi","Bilkent Ankara","6800",{"facility":1125,"status":30,"city":1126,"state":20,"zip":1127,"country":1105,"countryCode":20,"cosmosGeoPoint":1128,"geoPoint":1132,"contacts":20},"Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji","Istanbul","34899",{"type":37,"coordinates":1129},[1130,1131],28.94966,41.01384,{"lat":1131,"lon":1130},{"facility":1134,"status":30,"city":1126,"state":20,"zip":1135,"country":1105,"countryCode":20,"cosmosGeoPoint":1136,"geoPoint":1138,"contacts":20},"Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.","TBC",{"type":37,"coordinates":1137},[1130,1131],{"lat":1131,"lon":1130},{"facility":1140,"status":30,"city":1141,"state":20,"zip":1142,"country":1105,"countryCode":20,"cosmosGeoPoint":1143,"geoPoint":1147,"contacts":20},"Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast","Izmir","35210",{"type":37,"coordinates":1144},[1145,1146],27.13838,38.41273,{"lat":1146,"lon":1145},{"facility":1149,"status":30,"city":1150,"state":1151,"zip":1152,"country":1153,"countryCode":1154,"cosmosGeoPoint":1155,"geoPoint":1159,"contacts":20},"University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility","Leicester","Leicestershire","LE1 5WW","United Kingdom","UK",{"type":37,"coordinates":1156},[1157,1158],-1.13169,52.6386,{"lat":1158,"lon":1157},{"facility":1161,"status":30,"city":1162,"state":1163,"zip":1164,"country":1153,"countryCode":1154,"cosmosGeoPoint":1165,"geoPoint":1169,"contacts":20},"Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility","Liverpool","Merseyside","L122AP",{"type":37,"coordinates":1166},[1167,1168],-2.97794,53.41058,{"lat":1168,"lon":1167},{"facility":1171,"status":30,"city":1172,"state":1173,"zip":1174,"country":1153,"countryCode":1154,"cosmosGeoPoint":1175,"geoPoint":1179,"contacts":20},"Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology","Belfast","Northern Ireland","BT12 6BE",{"type":37,"coordinates":1176},[1177,1178],-5.92541,54.59682,{"lat":1178,"lon":1177},{"facility":1181,"status":30,"city":1182,"state":1183,"zip":1184,"country":1153,"countryCode":1154,"cosmosGeoPoint":1185,"geoPoint":1189,"contacts":20},"NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility","Glasgow","Scotland","G51 4TF",{"type":37,"coordinates":1186},[1187,1188],-4.25763,55.86515,{"lat":1188,"lon":1187},{"facility":1191,"status":30,"city":1192,"state":1193,"zip":1194,"country":1153,"countryCode":1154,"cosmosGeoPoint":1195,"geoPoint":1199,"contacts":20},"Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit","Newcastle upon Tyne","Tyne and Wear","NE7 7DN",{"type":37,"coordinates":1196},[1197,1198],-1.61396,54.97328,{"lat":1198,"lon":1197},{"facility":1201,"status":30,"city":1202,"state":1203,"zip":1204,"country":1153,"countryCode":1154,"cosmosGeoPoint":1205,"geoPoint":1209,"contacts":20},"Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility","Leeds","West Yorkshire","LS1 3EX",{"type":37,"coordinates":1206},[1207,1208],-1.54785,53.79648,{"lat":1208,"lon":1207},{"facility":1211,"status":30,"city":1212,"state":20,"zip":1213,"country":1153,"countryCode":1154,"cosmosGeoPoint":1214,"geoPoint":1218,"contacts":20},"University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility","Bristol","BS2 8AE",{"type":37,"coordinates":1215},[1216,1217],-2.59665,51.45523,{"lat":1217,"lon":1216},{"type":1220,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":1231,"type":1232},117,"ESTIMATED","INTERVENTIONAL",[1235],"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.",[1238,1239],"Left Ventricular Systolic Dysfunction","Heart Failure (Pediatric)","2026-06-26",{"date":1242,"type":1243},"2026-06-29","ACTUAL",{"date":1245,"type":1243},"2026-06-01",{"date":1247,"type":1232},"2030-12-30",{"name":5,"class":6},132]