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Jana Pawla II SPSK Nr 6 Slaskiego UM w Katowicach - Oddzial Kardiologii Dzieciecej","Katowice","40-752",{"type":45,"coordinates":903},[904,905],19.02173,50.2597,{"lat":905,"lon":904},{"facility":908,"status":394,"city":909,"state":25,"zip":910,"country":881,"countryCode":882,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Instytut Centrum Zdrowia Matki Polki w Lodzi - Klinika Kardiologii","Lódz","93-338",{"facility":912,"status":38,"city":913,"state":25,"zip":914,"country":915,"countryCode":916,"cosmosGeoPoint":917,"geoPoint":921,"contacts":25},"Hospital de Santa Cruz | Pediatric Cardiology Department","Carnaxide","2790-134","Portugal","PT",{"type":45,"coordinates":918},[919,920],-9.24671,38.72706,{"lat":920,"lon":919},{"facility":923,"status":38,"city":924,"state":25,"zip":925,"country":915,"countryCode":916,"cosmosGeoPoint":926,"geoPoint":930,"contacts":25},"Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Cardiologia Pediátrica","Coimbra","3004-561",{"type":45,"coordinates":927},[928,929],-8.41996,40.20686,{"lat":929,"lon":928},{"facility":932,"status":262,"city":933,"state":25,"zip":934,"country":915,"countryCode":916,"cosmosGeoPoint":935,"geoPoint":939,"contacts":25},"Hospital Santa Marta | Pediatric Cardiology Department","Lisbon","1169-024",{"type":45,"coordinates":936},[937,938],-9.1498,38.72509,{"lat":938,"lon":937},{"facility":941,"status":38,"city":942,"state":25,"zip":943,"country":915,"countryCode":916,"cosmosGeoPoint":944,"geoPoint":948,"contacts":25},"Unidade Local de Saúde de Santo António, E.P.E. - 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Lund - Barnhjärtcentrum","Lund","Skåne County","222 41","Sweden","SE",{"type":45,"coordinates":1058},[1059,1060],13.19321,55.70584,{"lat":1060,"lon":1059},{"facility":1063,"status":262,"city":1064,"state":25,"zip":1065,"country":1066,"countryCode":1067,"cosmosGeoPoint":1068,"geoPoint":1072,"contacts":25},"Kaohsiung Veterans General Hospital","Kaohsiung City","813414","Taiwan","TW",{"type":45,"coordinates":1069},[1070,1071],120.31333,22.61626,{"lat":1071,"lon":1070},{"facility":1074,"status":262,"city":1064,"state":25,"zip":1075,"country":1066,"countryCode":1067,"cosmosGeoPoint":1076,"geoPoint":1078,"contacts":25},"Chang Gung Memorial Hospital Kaohsiung","833",{"type":45,"coordinates":1077},[1070,1071],{"lat":1071,"lon":1070},{"facility":1080,"status":262,"city":1081,"state":25,"zip":1082,"country":1066,"countryCode":1067,"cosmosGeoPoint":1083,"geoPoint":1087,"contacts":25},"Taichung Veterans General Hospital","Taichung","40705",{"type":45,"coordinates":1084},[1085,1086],120.6839,24.1469,{"lat":1086,"lon":1085},{"facility":1089,"status":38,"city":1090,"state":25,"zip":1091,"country":1066,"countryCode":1067,"cosmosGeoPoint":1092,"geoPoint":1096,"contacts":25},"National Cheng Kung University Hospital","Tainan","704",{"type":45,"coordinates":1093},[1094,1095],120.21333,22.99083,{"lat":1095,"lon":1094},{"facility":1098,"status":262,"city":1099,"state":25,"zip":1100,"country":1066,"countryCode":1067,"cosmosGeoPoint":1101,"geoPoint":1105,"contacts":25},"National Taiwan University Hospital","Taipei","100225",{"type":45,"coordinates":1102},[1103,1104],121.52639,25.05306,{"lat":1104,"lon":1103},{"facility":1107,"status":262,"city":1099,"state":25,"zip":1108,"country":1066,"countryCode":1067,"cosmosGeoPoint":1109,"geoPoint":1111,"contacts":25},"MacKay Children's hospital","104217",{"type":45,"coordinates":1110},[1103,1104],{"lat":1104,"lon":1103},{"facility":1113,"status":262,"city":1114,"state":25,"zip":1115,"country":1116,"countryCode":25,"cosmosGeoPoint":1117,"geoPoint":1121,"contacts":25},"Cukurova Universitesi Tip Fakultesi Hastanesi","Adana","1330","Turkey (Türkiye)",{"type":45,"coordinates":1118},[1119,1120],35.32531,36.98615,{"lat":1120,"lon":1119},{"facility":1123,"status":38,"city":1124,"state":25,"zip":1125,"country":1116,"countryCode":25,"cosmosGeoPoint":1126,"geoPoint":1130,"contacts":25},"Hacettepe Universitesi Tip Fakultesi","Ankara","06230",{"type":45,"coordinates":1127},[1128,1129],32.85427,39.91987,{"lat":1129,"lon":1128},{"facility":1132,"status":262,"city":1133,"state":25,"zip":1134,"country":1116,"countryCode":25,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Ankara Bilkent Sehir Hastanesi","Bilkent Ankara","6800",{"facility":1136,"status":38,"city":1137,"state":25,"zip":1138,"country":1116,"countryCode":25,"cosmosGeoPoint":1139,"geoPoint":1143,"contacts":25},"Marmara Uni. Tip Fak. Pendik EAH Kardiyoloji","Istanbul","34899",{"type":45,"coordinates":1140},[1141,1142],28.94966,41.01384,{"lat":1142,"lon":1141},{"facility":1145,"status":38,"city":1137,"state":25,"zip":1146,"country":1116,"countryCode":25,"cosmosGeoPoint":1147,"geoPoint":1149,"contacts":25},"Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.","TBC",{"type":45,"coordinates":1148},[1141,1142],{"lat":1142,"lon":1141},{"facility":1151,"status":38,"city":1152,"state":25,"zip":1153,"country":1116,"countryCode":25,"cosmosGeoPoint":1154,"geoPoint":1158,"contacts":25},"Izmir Dr. Behcet Uz Cocuk Hastaliklari Hast","Izmir","35210",{"type":45,"coordinates":1155},[1156,1157],27.13838,38.41273,{"lat":1157,"lon":1156},{"facility":1160,"status":262,"city":1161,"state":1162,"zip":1163,"country":1164,"countryCode":1165,"cosmosGeoPoint":1166,"geoPoint":1170,"contacts":25},"University Hospitals of Leicester NHS Trust | Leicester Children's Hospital - Children's Research Facility","Leicester","Leicestershire","LE1 5WW","United Kingdom","UK",{"type":45,"coordinates":1167},[1168,1169],-1.13169,52.6386,{"lat":1169,"lon":1168},{"facility":1172,"status":262,"city":1173,"state":1174,"zip":1175,"country":1164,"countryCode":1165,"cosmosGeoPoint":1176,"geoPoint":1180,"contacts":25},"Alder Hey Children's NHS Foundation Trust | Alder Hey Children's Hospital - Clinical Research Facility","Liverpool","Merseyside","L122AP",{"type":45,"coordinates":1177},[1178,1179],-2.97794,53.41058,{"lat":1179,"lon":1178},{"facility":1182,"status":38,"city":1183,"state":1184,"zip":1185,"country":1164,"countryCode":1165,"cosmosGeoPoint":1186,"geoPoint":1190,"contacts":25},"Belfast Health and Social Care Trust | Royal Belfast Hospital for Sick Children - Paediatric Cardiology","Belfast","Northern Ireland","BT12 6BE",{"type":45,"coordinates":1187},[1188,1189],-5.92541,54.59682,{"lat":1189,"lon":1188},{"facility":1192,"status":38,"city":1193,"state":1194,"zip":1195,"country":1164,"countryCode":1165,"cosmosGeoPoint":1196,"geoPoint":1200,"contacts":25},"NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility","Glasgow","Scotland","G51 4TF",{"type":45,"coordinates":1197},[1198,1199],-4.25763,55.86515,{"lat":1199,"lon":1198},{"facility":1202,"status":38,"city":1203,"state":1204,"zip":1205,"country":1164,"countryCode":1165,"cosmosGeoPoint":1206,"geoPoint":1210,"contacts":25},"Newcastle upon Tyne Hospitals NHS Foundation Trust |Freeman Hospital - Children's Heart Unit","Newcastle upon Tyne","Tyne and Wear","NE7 7DN",{"type":45,"coordinates":1207},[1208,1209],-1.61396,54.97328,{"lat":1209,"lon":1208},{"facility":1212,"status":38,"city":1213,"state":1214,"zip":1215,"country":1164,"countryCode":1165,"cosmosGeoPoint":1216,"geoPoint":1220,"contacts":25},"Leeds Teaching Hospitals NHS Trust | Leeds Children's Hospital - Children's Research Facility","Leeds","West Yorkshire","LS1 3EX",{"type":45,"coordinates":1217},[1218,1219],-1.54785,53.79648,{"lat":1219,"lon":1218},{"facility":1222,"status":38,"city":1223,"state":25,"zip":1224,"country":1164,"countryCode":1165,"cosmosGeoPoint":1225,"geoPoint":1229,"contacts":25},"University Hospitals Bristol and Weston NHS Foundation Trust | Bristol Royal Hospital for Children - Clinical Research Facility","Bristol","BS2 8AE",{"type":45,"coordinates":1226},[1227,1228],-2.59665,51.45523,{"lat":1228,"lon":1227},{"type":1231,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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",false,"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.","ALL","6 Months","17 Years",{"count":1244,"type":1245},111,"ESTIMATED","INTERVENTIONAL",[1248],"PHASE3","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.",[1251,1252],"Left Ventricular Systolic Dysfunction","Heart Failure (Pediatric)","2026-06-12",{"date":1255,"type":1256},"2026-06-15","ACTUAL",{"date":1258,"type":1256},"2025-11-19",{"date":1260,"type":1245},"2029-12-30",{"name":5,"class":6},133]